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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
October 22, 2008
08-42
___________________________________
PRODUCT
a) Corn Muffins *** Los Nuevos Gemelos*** Net Wt 13 oz., Recall # F-002-9;
b) Pan de Maiz *** Los Nuevos Gemelos *** Net WT 15 oz., Recall # F-003-9;
c) Pound Cake de Maiz *** Los Nuevos Gemelos *** Net Wt 14 oz, Recall # F-004-9;
d) Pie de Pina *** Los Nuevos Gemelos *** Net Wt 14 oz, Recall # F-005-9
CODE
All Expirations Dates
RECALLING FIRM/MANUFACTURER
Los Nuevos Gemelos, Rio Piedras, PR, by telephone beginning on September 10, 2008. Firm initiated recall is ongoing.
REASON
Products contain undeclared colors - FD&C Yellow #5 and FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
PR
__________________________________
PRODUCT
a) Mercer's Butterscotch Ripple Ice Cream, Half Gallon, and
b) Mercer's Butterscotch Royal Ice Cream 3 Gallon sizes, UPC 0 36667 20011 8, Recall # F-006-9
CODE
a) 275;
b) 8241
RECALLING FIRM/MANUFACTURER
Quality Dairy Farms, Inc., Boonville, NY, by letters dated September 15, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
2 - 3 Gallon tubs and 274 Half Gallon containers
DISTRIBUTION
NY, WI
___________________________________
PRODUCT
a) Rize 2, The Occasion Capsules Sexual Performance Enhancer for Men, 469mg proprietary herbal blend, packaged in 1 capsule blister cards and 3, 12 and 30 capsule bottles, Recall # D-017-2009;
b) Rose 4 Her Capsules Sexual Enhancer for Women, 427mg proprietary herbal blend, packaged in 1 capsule blister cards and 3 capsule bottles, Recall # D-018-2009
CODE
a) CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10 Updated to all lots, July 28, 2008. Updated to all lots on July 28, 2008;
b) Lot number CG-78 expires 11/10). Updated to all lots on July, 28 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Devine Dist. DBA Jack Dist., Pompano Beach, FL, by press release, telephone and/or fax beginning on July 1, 2008.
Manufacturer: Innovative Products, Largo, FL. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product tested positive for thio-methisosildenafil an analog of sildenafil. Sildenafil is the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
2,400,000 capsules
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Hyoscyamine Sulfate Tablets SL, 0.125 mg, Sublingual/Oral/Chewable, Rx only, 100 Tablets, NDC 00904-5120-60, Recall # D-004-2009;
b) Hyoscyamine Sulfate Tablets, 0.125 mg, Rx only, 100 tablets, NDC # 00904-2496-60, Recall # D-005-2009;
c) Chewable Tri-a-vite w/FL Tablets, 1 mg, Rx only, 100 Tablets, NDC 0904-7810-60, Recall # D-006-2009;
d) Formula B Tablets (Vitaplex), Rx only, 100 Tablets, NDC 0904-2630-60, Recall # D-007-2009;
e) Bellamine-S Tablets, Rx only, 100 Tablets, NDC 0904-2548-60, Recall # D-008-2009;
f) Guanfacine Tablets, USP, 1 mg, 100 Tablets, Rx only, NDC 0904-5579-60, Recall # D-009-2009;
g) Multi Vita-Bets with Fluoride Chewable Tablets, Multivitamin and Fluoride Supplement, 0.25 mg, Rx only, 100 and 1000 Tablets, NDC 0904-5274-60, Recall # D-010-2009;
h) Multi Vita-Bets with Fluoride Chewable Tablets, Multivitamin and Fluoride Supplement, 0.5 mg, Rx only, 100 and 1000 Tablets, NDC 0904-5274-60, Recall # D-011-2009
CODE
a) All lots within expiry. Lot 5466A1, Exp. June 08; Lot 61095A1, Exp Dec 08; 70166A1, Exp Feb 09; 70306A1, Exp. Apr 09; 70548A1, Exp Jul 09; 70669A1, Exp Aug 09; 75757A2, Exp. Sep 09;
b) All lots within expiry Lot number 5429A1, Exp May 08; 5430A1, Exp. May 08; 70074A1, Exp. Jan 09; 70268A1, Exp Mar 09; 70626A1, Exp Jul 09; 70751A1, Exp Sep 09;
c) All lots within expiry, including Lot 60617A1, Exp. Jul 08; 70479A1, Exp Jun 09;
d) All lots within expiry including: Lot 61045A2, Exp. Nov 08; 70923A3, Exp. Nov. 09;
e) All lots within expiry including Lot 5474A1, Exp Jul 08, 60933A1, Exp Oct 08;
f), g) h) All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Harvard Drug Group, L.L.C., Livonia, MI, by letters on May 9, 2008, May 21st and June 10, 2008.
Manufacturer: Actavis Totowa LLC, Totowa NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviations; lack of stability indicating methods.
VOLUME OF PRODUCT IN COMMERCE
50,987 bottles
DISTRIBUTION
Nationwide and Grand Cayman Islands
___________________________________
PRODUCT
Micardis® HCT (telmisartan and hydrochlorothiazide) Tablets, 40mg/12.5mg, 7-tablet blister strip in folding carton, professional sample, Rx-only, NDC 0597-0043-70, Recall # D-012-2009
CODE
Lot 605396A, exp. May 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by letters on September 16, 2008.
Manufacturer: Boehringer Ingelheim Roxane Inc., Columbus, OH. Firm initiated recall is ongoing.
REASON
Professional sample folding cartons labeled Micardis® HCT 40mg/12.5mg may contain blister strip for Micardis® HCT 80mg/12.5mg tablets which could result in double intended dose of telmisartan.
VOLUME OF PRODUCT IN COMMERCE
103,284 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Thyro-Tab (levothyroxine sodium tablets), 0.050 mg, packaged in bulk drums intended for repackaging, Rx only, Recall # D-013-2009;
b) Levothroid (levothyroxine sodium tablets, USP), 50 mcg, packaged in 100- and 1,000-tablet bottles, NDC #0456-1321-01 (100-tab) and NDC #0456-1321-00 (1,000-tab), RX only, Recall # D-014-2009
CODE
a) Lots: HA17607, HB17607, HC17607 (Exp. July 2008) and HA21107, HB21107 (Exp. Aug 2008);
b) Lots: 070743, 070744, 070745, 080709, 080710, 080711 (exp. July 2008) and 080735, 080740 (exp. Aug 2008)
RECALLING FIRM/MANUFACTURER
Lloyd Inc., of Iowa, Shenandoah, IA, by letters dated June 18, 2008 and June 26, 2008. Firm initiated recall is ongoing.
REASON
Product may not maintain potency over shelf life.
VOLUME OF PRODUCT IN COMMERCE
Thyro-Tab - 19,296,674 tablets; Levothroid - 49,103/100-tablet bottles & 1,932/1,000-tablet bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Detrol (tolterodine tartrate) tablets, 2mg, blister strips in unit dose carton (10 blisters x 14 tablets), Rx only, For institutional use only, NDC 0009-4544-01, Recall # D-023-2009
CODE
Lot C081255, exp. April 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc, New York, NY, by letters on September 12, 2008.
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
The barcode on the blister strip incorrectly encodes NDC for 1mg Detrol. Barcode on outer carton is correct. All human-readable text is correct.
VOLUME OF PRODUCT IN COMMERCE
525 cartons (10 blisters x 14 tablets each)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Aldara cream (Imiquimod) 5%, 12.5mg imiquimod per packet, 24 single use packets per box, Rx only, NDC 29336-610-24, Recall # D-025-2009
CODE
Lot: JA072A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Graceway Pharmaceuticals LLC, Bristol, TN, by fax and email on September 16, 2008 .
Manufacturer: 3M Health Care, Ltd., Loughborough, United Kingdom. Firm initiated recall is ongoing.
REASON
Product is leaking from packets.
VOLUME OF PRODUCT IN COMMERCE
12,891 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0001-09;
b) Platelets, Recall # B-0002-09;
c) Fresh Frozen Plasma, Recall # B-0003-09;
d) Red Blood Cells Leukocytes Reduced, Recall # B-0004-09
CODE
a) Unit: 033GF06971;
b) and d) Unit: 033LV62427;
c) Units: 033GF06971, 033LV62427
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone/ facsimile on July 19, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing repeat reactive for the antibody to Hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CT
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0005-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0006-09;
c) Platelets; Recall # B-0007-09;
d) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0008-09;
e) Fresh Frozen Plasma (Apheresis), Recall # B-0009-09;
f) Platelets Irradiated, Recall # B-0010-09;
g) Platelets Pheresis Leukocytes Reduced, Recall # B-0011-09
CODE
a) Units: 6251508, 6249857, 6254792, 6248375, 6250131, 6251049, 6249880, 6251050, 6251053, 6249876, 6251052, 6251056, 6251044, 6251046, 6249882, 6257979, 6254800, 6249873, 6255146, 6248374, 6251509, 6254812, 6250152, 6255115, 6250149, 6248295, 6251054, 6251516, 6248143, 6253259, 6253076, 6254918, 6255224, 6253264, 6255131, 6255132, 6250365, 6249875, 6251051, 6249925, 6250368, 6250050, 6251042, 6250127, 6251512, 6254793, 6250129, 6250137, 6250216, 6250125, 6249859, 6257894, 6255117, 6253074, 6254923, 6254928, 6254710, 6254711, 6255162, 6251510, 6250153, 6251043, 6255070, 6257885, 6250128, 6248554, 6248417, 6248555, 6253266, 6250384, 6250383, 6252879, 6254925, 6257948, 6253075, 6250372, 6250215, 6257794, 6257863, 6250134, 6257890, 6251200, 6254976, 6257881, 6250285, 6254920, 6254911, 6254910, 6258035, 6251518, 6255153, 6251513, 6251514, 6250133, 6250144, 6250135, 6248045, 6254906, 6248499, 6253255, 6251511, 6253256, 6253257, 6248497, 6249858, 6253071, 6250150, 6253023, 6250270, 6255007, 6248533, 6253072, 6252877, 6253073, 6254908, 6257980, 6255151, 6254924, 6255213, 6255225, 6258030, 6254914, 6258033, 6254975, 6254985, 6254973, 6258170, 6257895, 6255116, 6255139, 6255145, 6257893, 6251036, 6251055, 6248265, 6251048, 6251045, 6248376, 6254722, 6251257, 6248424, 6254799, 6250005, 6250030, 6250107, 6249944, 6249885, 6250138, 6248425, 6248463, 6248492, 6249874, 6249881, 6249883, 6254749, 6252950, 6252961, 6252960, 6252962, 6251507, 6256481, 6251621, 6251520, 6251521, 6257897;
b) Units: 6249859, 6253331, 6250131, 6253329, 6249858, 6254792, 6253080, 6250129, 6250140, 6250152, 6250365, 6250366, 6255145, 6255152, 6250107, 6248375, 6249925, 6250368, 6254708, 6250383, 6250269, 6246410, 6246701, 6251202, 6248266, 6251045, 6249845, 6256508, 6249876, 6254920, 6256474, 6253073, 6252950, 6255225, 6249875, 6252951, 6249857, 6256739, 6251518, 6249883, 6256742, 6249873, 6248143, 6250375, 6254749, 6251194, 6249874, 6250391, 6252956, 6257893, 6254914, 6250370, 6253074, 6253144, 6254722, 6253165, 6256788, 6252976, 6250127, 6252979, 6257939, 6250379, 6257948, 6253160, 6255132, 6248295, 6255131, 6253179, 6258005, 6253253, 6256770, 6256791, 6256817, 6256814, 6256760, 6251257, 6254908, 6254911, 6253084, 6246711, 6246708, 6254910, 6257820, 6249909, 6247415, 6257671, 6256670, 6253202, 6253339, 6257681, 6256721, 6250168, 6254793, 6256815, 6256809, 6250142, 6258169, 6249843, 6256808, 6250138, 6250184, 6250135, 6250285, 6250161, 6250183, 6250126, 6250373, 6253182, 6253166, 6251052, 6251051, 6251044, 6253359, 6253366, 6258033, 6253077, 6253081, 6252903, 6253088, 6253132, 6253143, 6253082, 6254647, 6257691, 6250377, 6255004, 6250390, 6255162, 6250389, 6250388, 6258175, 6251510, 6253255, 6255151, 6250378, 6257895, 6250134, 6251451, 6250376, 6256467, 6250372, 6258030, 6252975, 6252955, 6252952, 6246415, 6252977, 6253334, 6251516, 6249880, 6253264, 6256527, 6258170, 6253133, 6251513, 6258029, 6253071, 6248324, 6253076, 6253338, 6251450, 6250374, 6248265, 6250137, 6251453, 6250128, 6257638, 6257818, 6250030, 6254694, 6255213, 6256671, 6248157, 6257897, 6250143, 6249906, 6250130, 6248466, 6256993, 6248554, 6253254, 6253340, 6249836, 6256727, 6255000, 6249854, 6250182, 6253350, 6256723, 6250172, 6257885, 6256816, 6248555, 6248425, 6250175, 6256707, 6255015, 6254995, 6246704, 6257822, 6254812, 6250216, 6251036, 6253328, 6254973, 6251200, 6251048, 6250384, 6255021, 6250380, 6254693, 6250381, 6250382, 6256716, 6253425, 6250385, 6254999, 6254996, 6254711, 6253083, 6252953, 6252954, 6252960, 6252961, 6256564, 6258006, 6256547, 6256528, 6257980, 6256472, 6257979, 6253180, 6257894, 6253256, 6255070, 6251242, 6257794, 6251252, 6253183, 6253089, 6253259, 6251297, 6254925, 6251509, 6256738, 6256722, 6250144, 6248323, 6250133, 6248326, 6248533, 6247383, 6248499, 6249884, 6249881, 6249885, 6255116, 6255115, 6256821, 6248376, 6248556, 6256898, 6250050, 6250148, 6250146, 6249832, 6248374, 6250125, 6251449, 6248497, 6249944, 6255078, 6254649, 6254645, 6254644, 6254648, 6254976, 6257641, 6250386, 6248424, 6250151, 6254985, 6249882, 6257682, 6254646, 6254918, 6254924, 6254928, 6255153, 6254929, 6256476, 6258035, 6256717, 6254922, 6254923, 6254906, 6254975, 6255117, 6257863, 6257668, 6256887, 6257823, 6255146, 6255139, 6257878, 6257890, 6257881, 6248325, 6251055, 6248045, 6251054, 6251053, 6251049, 6251046, 6251043, 6248417, 6251042, 6251050, 6251298, 6251253, 6251056, 6250215, 6254799, 6254800, 6253072, 6251204, 6254710, 6250140, 6250005, 6250139, 6250145, 6250150, 6250270, 6250153, 6248552, 6248463, 6250393, 6248492, 6249844, 6253177, 6253181, 6253257, 6253200, 6253201, 6253175, 6253131, 6252978, 6253174, 6253146, 6256563, 6253148, 6252962, 6256562, 6251517, 6251511, 6253337, 6251519, 6256517, 6256481, 6253070, 6253023, 6251520, 6253261, 6253330, 6253267, 6251621, 6253266, 6253079, 6254967, 6253332, 6250147;
c) Units: 6254646, 6248157, 6253330, 6253165, 6250107, 6254924, 6254985, 6254812, 6257878, 6253133, 6251516, 6253070, 6253072, 6251517, 6251450, 6253332, 6248265, 6248266, 6253329, 6253328, 6257820, 6256563, 6250138, 6248499, 6251511, 6251509, 6248497, 6254923, 6252962, 6255153, 6252961, 6252960, 6249858, 6257638, 6252513, 6248533, 6248374, 6258006, 6253179, 6253180, 6253177, 6251451, 6254693, 6255145, 6254694, 6254918, 6254973, 6256742, 6251194, 6250381, 6250382, 6255117, 6257794, 6251202, 6251520, 6256547, 6256467, 6256517, 6255131, 6251257, 6249883, 6250128, 6250129, 6250131, 6250135, 6250140, 6250137, 6250139, 6250005, 6256671, 6256739, 6255116, 6250147, 6256738, 6256815, 6255162, 6256788, 6254914, 6255224, 6256770, 6256809, 6256760, 6254976, 6256898, 6255139, 6256817, 6255146, 6248045, 6248376, 6248554, 6248417, 6250127, 6248463, 6249857, 6256528, 6253266, 6256527, 6253264;
d) Units: 6256449, 6256851, 6251276, 6251269, 6251283, 6251283, 6248384, 6236490, 6254663, 6236485, 6236490, 6251327, 6251121, 6252999, 6256456, 6248384, 6256449, 6236485, 6248584, 6248570, 6256851, 6248584, 6248570, 6256643, 6256445, 6236488, 6236488, 6254861, 6248586, 6256866, 6248586, 6236482, 6248598, 6251293, 6251128, 6251332, 6248573, 6251292, 6251327, 6248573, 6251121, 6248612, 6250193, 6257735, 6251288, 6253374, 6252857, 6256457, 6256456, 6251288, 6257735, 6257730, 6251269, 6251276, 6256445, 6252857, 6236484, 6256922, 6256922, 6257730, 6251098, 6251127, 6251127, 6255026, 6250359, 6250359, 6256595, 6254861, 6251279, 6251279, 6251287, 6255183, 6256595, 6236482, 6236491, 6248612, 6256831, 6236491, 6248601, 6251119, 6251119, 6252999, 6256459, 6254859, 6256459, 6254855, 6254859, 6254853, 6256457, 6254962, 6256878, 6255045, 6258105, 6256885, 6254945, 6254959, 6254954, 6254958, 6251332, 6251329, 6251293, 6251292, 6251287, 6254853, 6254855, 6236484, 6249990, 6250316, 6250315, 6248598, 6248600, 6248601, 6253000, 6253000, 6252985, 6252927, 6252851, 6252992, 6252982, 6252982, 6252985, 6252990, 6252990, 6252995, 6252995, 6252992, 6253374, 6252851, 6251470, 6253396, 6253396, 6253397, 6253397, 6253399, 6253399, 6251128, 6249985, 6248600;
e) Units: 6255034 (Part A and B);
f) Unit: 6250391;
g) Units: 6255196, 6255045, 6253290, 6253229, 6248517, 6248517, 6249985, 6249953, 6256946, 6254941, 6253227, 6251470, 6255031, 6255026, 6250323, 6254950, 6254941, 6258105, 6248524, 6249995, 6249959, 6254954, 6256689, 6256687, 6254934, 6256689, 6255196, 6255185, 6255183, 6256879, 6256879, 6256878, 6256872, 6257708, 6257708, 6254962, 6254962, 6254962, 6256872, 6255029, 6255035, 6256946, 6255034, 6255029, 6257708, 6258064, 6256885, 6256883, 6254952, 6256643, 6254952, 6254950, 6254949, 6254949, 6254954, 6254945, 6256687, 6254961, 6256872, 6254961, 6254959, 6254959, 6254959, 6256871, 6254934, 6256871, 6254958, 6256869, 6256866, 6251098, 6251103, 6251221, 6249990, 6250315, 6250193, 6250193, 6248523, 6249965, 6248524, 6251215, 6254834, 6248523, 6252927, 6252927, 6253243, 6252945, 6253227, 6251473, 6251473, 6253290, 6248524, 6249953
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on April 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
867 units
DISTRIBUTION
MS, AR, AL, CA, MI, FL, Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0014-09;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0015-09;
c) Plasma Frozen, Recall # B-0016-09
CODE
a) Units: 04KZ13815, 04KZ13818, 04KZ13820, 04KZ13821, 04KZ13823,
04KZ13825, 04LC46434, 04LC46436, 04LC46438, 04LC46440, 04LC46442,
04LC46444, 04LC46454, 04LC46772, 04LC46776, 04LC46784, 04LJ52068,
04LJ52073, 04LJ52082, 04LJ52088, 04LJ52092, 04LJ52101, 04LJ52105, 04LJ52113,
04LJ52124, 04LJ52131, 04LJ52260, 04LJ52266, 04LJ52278, 04LJ52279, 04LJ52283,
04LJ52287, 04LJ52288, 04LQ80401, 04LQ80404, 04LQ80410, 04LQ80415,
04LQ80429, 04LQ80432, 04LQ80436, 04LQ80441, 04LQ80442, 04LQ80454,
04LQ80714, 04LQ80716, 04LQ80723, 04LQ80725, 04LQ80728, 04LQ80743,
04LQ80773, 04LQ80778, 04LQ80784, 04LQ80794, 04LQ80795, 04LQ80799,
04LQ80802, 04LQ80807, 04LQ80813, 04LQ80817, 04LQ80818, 04LQ80740;
b) Unit: 04LQ80732;
c) Unit: 04LQ80794
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by telephone and follow-up letters on June 22, 2007 and July 23, 2007.
Manufacturer: American National Red Cross ARC Blood, Services N.E. Region
Burlington, VT. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
MA, VT, NH, NY, ME
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0019-09
CODE
Unit: 019GE23585
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone, electronically and fax on March 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN, CA
___________________________________
PRODUCT
a) Platelets, Recall # B-0024-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0025-09
CODE
a) and b) Unit: 2878624
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc, Orlando, FL, by telephone on October 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was deferred for a body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0029-09
CODE
Unit: 9909953 (Part 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc, Orlando, FL, by telephone on July 16, 2007. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0046-09
CODE
Unit: GP19223 (split unit)
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter on April 13, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0050-09;
b) Plasma Frozen, Recall # B-0051-09
CODE
a) Units: 38E29507, 38E29515, 38E29516, 38E29522, 38E29525 and 38E29527;
b) Units: 38E29507, 38E29522 and 38FV72269
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter on January 17, 2008. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air during collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA, IN, ID
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0053-09
CODE
Unit: N53495
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter dated June 18, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0072-09
CODE
Units: 7221567, 7213546, 3786729, 3780456
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by facsimile on August 16, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0084-09;
b) Platelets Leukocytes Reduced, Recall # B-0085-09
CODE
a) and b) Unit: 019GP35599
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and letter on September 27, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, KY
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0091-09;
b) Platelets Leukocytes Reduced, Recall # B-0092-09
CODE
a) and b) Unit: 019LJ29946
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and electronic notification on April 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, TN, KY
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0094-09;
b) Platelets Leukocytes Reduced, Recall # B-0095-09
CODE
a) and b) Unit: 019LS61651
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter on June 12, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0099-09;
b) Platelets Leukocytes Reduced, Recall # B-0100-09
CODE
a) and b) Unit: 019LS58709
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and telephone on May 9, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0110-09
CODE
Unit: LG49136
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter dated May 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0111-09;
b) Plasma, Recall # B-0112-09;
c) Cryoprecipitated AHF, Recall # B-0113-09
CODE
a), b) and c) Unit: LM47654
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by telephone, letter, or electronic notification on May 12, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
RI, Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0116-09;
b) Platelets Leukocytes Reduced, Recall # B-0117-09
CODE
a) and b) Unit: LM52542
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter dated April 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
RI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0118-09;
b) Recovered Plasma, Recall # B-0119-09
CODE
a) and b) Unit: 54KM00587
RECALLING FIRM/MANUFACTURER
American National Red Cross, Rio Piedras, PR, by telephone on May 9, 2007, facsimile on May 10, 2007, or by letter dated May 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PR and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0134-09;
b) Fresh Frozen Plasma, Recall # B-0135-09
CODE
a) and b) Unit: 2255344
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys, CA, by letter on February 5, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor who had been deferred due to high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0136-09;
b) Fresh Frozen Plasma, Recall # B-0137-09
CODE
a) and b) Units: 4016807
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys, CA, by letter on February 5, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received the rabies vaccine within one year of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Platelets, Recall # B-0138-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0140-09
CODE
a) and b) Unit: 2807903
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 16, 2007 and by letter on April 9, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0141-09
CODE
Unit: 2539457 (2 units)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated May 30, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III ___________________________________
PRODUCT
Recovered Plasma, Recall # B-0012-09
CODE
Units: 6253120, 6252877, 6251521, 6251507, 6251508, 6253075, 6251512, 6251514, 6256474, 6257682, 6256517, 6257878, 6253143, 6253120, 6256791, 6253332, 6256887, 6257819, 6257818, 6248466, 6249906, 6256671, 6256674, 6254929, 6250142, 6250130, 6251519, 6249884, 6254915, 6252956, 6250380, 6250373, 6258005, 6250269, 6250374, 6250376, 6250366, 6250370, 6250375, 6250377, 6252955, 6251450, 6251449, 6251253, 6251453, 6251252, 6251242, 6251204, 6251202, 6251194, 6252951, 6252952, 6252953, 6250393, 6250391, 6250385, 6252979, 6252978, 6252977, 6250379, 6252976, 6252954, 6250382, 6251451, 6252975, 6250386, 6250388, 6250389, 6250390, 6250378, 6250381, 6253329, 6257691, 6253180, 6253181, 6253182, 6253200, 6253201, 6253202, 6253253, 6253254, 6253260, 6253261, 6253177, 6253328, 6253175, 6253330, 6257823, 6253331, 6257822, 6257820, 6253334, 6253337, 6253338, 6253339, 6253425, 6254644, 6248552, 6253267, 6253084, 6256472, 6256467, 6256527, 6256528, 6256547, 6256562, 6256564, 6253077, 6253079, 6253080, 6253081, 6253179, 6253083, 6254646, 6253088, 6253089, 6253131, 6253132, 6253133, 6253144, 6253146, 6253148, 6253160, 6253165, 6253166, 6253174, 6253082, 6256739, 6254645, 6256817, 6256816, 6256815, 6256814, 6256809, 6256808, 6256788, 6256770, 6256476, 6256760, 6248354, 6248556, 6248326, 6256738, 6249909, 6256670, 6250126, 6250139, 6250140, 6250143, 6250145, 6250146, 6250147, 6250148, 6250151, 6256742, 6246410, 6254647, 6254648, 6257681, 6254649, 6257671, 6254693, 6257668, 6254694, 6257641, 6254708, 6257638, 6256821, 6246407, 6255078, 6246415, 6246701, 6246704, 6246708, 6246711, 6247383, 6247415, 6248157, 6248266, 6248323, 6248324, 6248325, 6256898
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on April 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
183 units
DISTRIBUTION
MS, AR, AL, CA, MI, FL, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0017-09
CODE
Unit: 029KF42376
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by letter on July 23, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not properly recorded, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0018-09
CODE
Unit: 019GE23585
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone, electronically and fax on March 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN, CA
___________________________________
PRODUCT
Source Plasma, Recall # B-0021-09
CODE
Unit: 365030622
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Roanoke, VA, by fax on October 12, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0022-09
CODE
Unit: 174054517
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Roanoke, VA, by fax on October 13, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Plasma Frozen, Recall # B-0086-09
CODE
Unit: 019GP35599
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and letter on September 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN, KY
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0090-09
CODE
Unit: 019LJ29946
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and electronic notification on April 11, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, TN, KY
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0093-09
CODE
Unit: 019LS61651
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter on June 12, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0098-09
CODE
Unit: 019LS58709
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and telephone on May 9, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, TN
___________________________________
PRODUCT
The hood assembly for the Abbott m2000sp (List 9K14-01 and 9K14-02) Automated Sample Preparation System, Recall # B-0109-09
CODE
All units with hood assemblies
RECALLING FIRM/MANUFACTURER
Abbott Molecular Inc., Des Plaines, IL, by letters dated August 25, 2008. Firm initiated recall is ongoing.
REASON
Hood front windows that may detach from the window stud plates that attach the window to the m2000sp Instrument, possibly harming the instrument user, were distributed.
VOLUME OF PRODUCT IN COMMERCE
77 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0139-09
CODE
Unit: 2807903
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 16, 2007 and by letter on April 9, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0142-09
CODE
Unit: 2091593
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated May 16, 2007. Firm initiated recall is complete.
REASON
Blood product, which may have been manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0143-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0144-09
CODE
a) Units: W041608007057C (2 units);
b) Units: W0416080050825, W041608006850F, W041608007048E, W041608007066A, W0416080070678, W041608007074A, W0416080282088
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on May 6, 2008.
Manufacturer: Blood Systems Inc/dba United Blood Services, Hattiesburg, MS. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0145-09
CODE
Units: 161678979 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on October 30, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, Enterococcus species, and coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MS, AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0146-09
CODE
Unit: 160291693
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on November 14, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-0147-09;
b) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0148-09
CODE
a) Units: 160294771 (Parts 1 & 2);
b) Units: 160288357, 160291716, 161669954, 161669957 (2 units), 161670033, 161678935, 161681614, 161681624, 161681715, 163943715, 163943715, 163943719
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on November 15, 2007 and December 3, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not leukoreduced within the required timeframe after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
MS, AL, LA
___________________________________
PRODUCT
Ultraview Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including a systole, ventricular fibrillation and ventricular tachycardia, Recall # Z-2336-2008
CODE
Serial numbers: 1341-000517, 1341-000518, 1341-000519, 1341-000521, 1341-000524, 1341-000525, 1341-000526, 1341-000527, 1341-000528, 1341-000529, 1341-000530, 1341-000531, 1341-000532, 1341-000533, 1341-000534, 1341-000535, 1341-000536, 1341-000537, 1341-000538, 1341-000539, 1341-000540, 1341-000541, 1341-000543, 1341-000544, 1341-000545, 1341-000546, 1341-000547, 1341-000548, 1341-000549, 1341-000550, 1341-000551, 1341-000552, 1341-000553, 1341-000556, 1341-000557, 1341-000558, 1341-000559, 1341-000560, 1341-000561, 1341-000562, 1341-000563, 1341-000564, 1341-000565, 1341-000566, 1341-000570, 1341-000571, 1341-000572, 1341-000573, 1341-000574, 1341-000575, 1341-000576, 1341-000577, 1341-000578, 1341-000579, 1341-000580, 1341-000582, 1341-000583, 1341-000584, 1341-000585, 1341-000586, 1341-000587, 1341-000589, 1341-000590, 1341-000591, 1341-000592, 1341-000593, 1341-000594, 1341-000595, 1341-000596, 1341-000597, 1341-000598, 1341-000599, 1341-000600, 1341-000601, 1341-000602, 1341-000603, 1341-000604, 1341-000605, 1341-000606, 1341-000607, 1341-000611, 1341-000612, 1341-000613, 1341-000614, 1341-000615, 1341-000616, 1341-000617, 1341-000618, 1341-000619, 1341-000620, 1341-000621, 1341-000622, 1341-000623, 1341-000624, 1341-000625, 1341-000626, 1341-000627, 1341-000628, 1341-000630, 1341-000631, 1341-000632, 1341-000633, 1341-000634, 1341-000635, 1341-000636, 1341-000637, 1341-000638, 1341-000639, 1341-000640, 1341-000641, 1341-000642, 1341-000643, 1341-001239, 1341-001240, 1341-000245, 1341-000246, 1341-000247, 1341-000248, 1341-000250, 1341-000251, 1341-000252, 1341-000253, 1341-000254, 1341-000255, 1341-000256, 1341-000257, 1341-000508, 1341-000509, 1341-000510, 1341-000511, 1341-000512, 1341-000513, 1341-000514, 1341-000699, 1341-000700, 1341-001029, 1341-001033, 1341-001034, 1341-001035, 1341-001037, 1341-001038, 1341-001039, 1341-001040, 1341-001041, 1341-001042, 1341-001043, 1341-001045, 1341-001046, 1341-001047, 1341-001048, 1341-001049, 1341-001050, 1341-001051, 1341-001053, 1341-001055, 1341-001056, 1341-001057, 1341-001058, 1341-001059, 1341-001095, 1341-001242, 1341-001244, 1341-001390, 1341-001391, 1341-001393, 1341-001394, 1341-001395, 1341-001396, 1341-001397, 1341-001398, 1341-001399, 1341-001400, 1341-001401, 1341-001428, 1341-001429, 1341-001446, 1341-001448, 1341-001450, 1341-001452, 1341-001454, 1341-001455, 1341-001456, 1341-001457, 1341-001636, 1341-001637, 1341-001638, 1341-001639, 1341-001640, 1341-001749, 1341-001750, 1341-001933, 1341-001934, 1341-001935, 1341-001936, 1341-001937, 1341-001938, 1341-001952, 1341-001953, 1341-001954, 1341-001955, 1341-001956, 1341-001957, 1341-001958, 1341-001959, 1341-001960, 1341-001940, 1341-001941, 1341-001942, 1341-001943, 1341-001944, 1341-001945, 1341-001946, 1341-001947, 1341-001948, 1341-001949, 1341-001950, 1341-001951, 1341-001234, 1341-001235, 1341-001236, 1341-001237, 1341-001372, 1341-001373, 1341-001374, 1341-001375, 1341-001376, 1341-001377, 1341-000098, 1341-000099, 1341-000100, 1341-000101, 1341-000102, 1341-000103, 1341-000104, 1341-000105, 1341-000106, 1341-000107, 1341-000108, 1341-000109, 1341-000110, 1341-000111, 1341-000112, 1341-000113, 1341-000114, 1341-000115, 1341-000234, 1341-000235, 1341-000236, 1341-000237, 1341-000238, 1341-000239, 1341-000240, 1341-000241, 1341-000242, 1341-000243, 1341-000244, 1341-000260, 1341-000261, 1341-000262, 1341-000263, 1341-000264, 1341-000265, 1341-000266, 1341-000427, 1341-000428, 1341-000429, 1341-000430, 1341-000431, 1341-000432, 1341-000433, 1341-000434, 1341-000435, 1341-000436, 1341-000437, 1341-000438, 1341-000439, 1341-000440, 1341-000441, 1341-000442, 1341-000443, 1341-000444, 1341-000445, 1341-000446, 1341-000830, 1341-000831, 1341-000832, 1341-000833, 1341-000834, 1341-000835, 1341-000836, 1341-000837, 1341-000838, 1341-000839, 1341-000840, 1341-000841, 1341-000842, 1341-000843, 1341-000844, 1341-000845, 1341-000846, 1341-000847, 1341-000848, 1341-000849, 1341-000850, 1341-000851, 1341-000852, 1341-000853, 1341-000854, 1341-000855, 1341-000856, 1341-000857, 1341-000858, 1341-000859, 1341-000860, 1341-000861, 1341-000862, 1341-000863, 1341-000864, 1341-000865, 1341-000866, 1341-000867, 1341-000868, 1341-000869, 1341-000870, 1341-000871, 1341-000872, 1341-000873, 1341-000874, 1341-000875, 1341-000876, 1341-000877, 1341-000878, 1341-000879, 1341-000880, 1341-000881, 1341-000882, 1341-000883, 1341-000884, 1341-000885, 1341-000886, 1341-000887, 1341-000888, 1341-000889, 1341-000890, 1341-000891, 1341-000892, 1341-000893, 1341-000894, 1341-000895, 1341-000896, 1341-000897, 1341-000898, 1341-000899, 1341-000900, 1341-000901, 1341-000902, 1341-000903, 1341-000904, 1341-000905, 1341-000906, 1341-000907, 1341-000908, 1341-000909, 1341-000910, 1341-000911, 1341-000912, 1341-000913, 1341-000914, 1341-000915, 1341-000916, 1341-000917, 1341-000918, 1341-000919, 1341-000920, 1341-000921, 1341-000922, 1341-000923, 1341-000924, 1341-001145, 1341-001146, 1341-001147, 1341-001148, 1341-001149, 1341-001150, 1341-001151, 1341-001649, 1341-001096, 1341-001097, 1341-001098, 1341-001099, 1341-001100, 1341-001101, 1341-001102, 1341-001103, 1341-001104, 1341-001105, 1341-001106, 1341-001107, 1341-001108, 1341-001109, 1341-001110, 1341-001111, 1341-001112, 1341-001113, 1341-001114, 1341-001115, 1341-001116, 1341-001117, 1341-001118, 1341-001119, 1341-001120, 1341-001121, 1341-001122, 1341-001123, 1341-001124, 1341-001125, 1341-001126, 1341-001127, 1341-001128, 1341-001129, 1341-001130, 1341-001131, 1341-001132, 1341-001133, 1341-001134, 1341-001135, 1341-001136, 1341-001137, 1341-001138, 1341-001139, 1341-001202, 1341-001203, 1341-001204, 1341-001205, 1341-001206, 1341-001207, 1341-001208, 1341-001209, 1341-001210, 1341-001211, 1341-001212, 1341-001213, 1341-001214, 1341-001215, 1341-001216, 1341-001249, 1341-001250, 1341-001251, 1341-001252, 1341-001253, 1341-001254, 1341-001255, 1341-001256, 1341-001257, 1341-001258, 1341-001259, 1341-001260, 1341-001261, 1341-001262, 1341-001263, 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1341-000277, 1341-000278, 1341-000279, 1341-000280, 1341-000281, 1341-000282, 1341-000283, 1341-000284, 1341-000285, 1341-000286, 1341-000287, 1341-000288, 1341-000289, 1341-000290, 1341-000291, 1341-000292, 1341-000293, 1341-000294, 1341-000295, 1341-000296, 1341-000297, 1341-000298, 1341-000299, 1341-000300, 1341-000301, 1341-000302, 1341-000303, 1341-001285, 1341-001299, 1341-001300, 1341-001301, 1341-001302, 1341-001303, 1341-001304, 1341-001305, 1341-001306, 1341-001307, 1341-001308, 1341-001309, 1341-001310, 1341-001311, 1341-001312, 1341-001313, 1341-001314, 1341-001315, 1341-001316, 1341-001317, 1341-001318, 1341-001319, 1341-001320, 1341-001321, 1341-001322, 1341-001323, 1341-001324, 1341-001325, 1341-001326, 1341-001327, 1341-001328, 1341-001329, 1341-001330, 1341-001331, 1341-001332, 1341-001333, 1341-001334, 1341-001335, 1341-001336, 1341-001337, 1341-001338, 1341-001339, 1341-001340, 1341-001341, 1341-001342, 1341-001343, 1341-001344, 1341-001345, 1341-001346, 1341-001347, 1341-001348, 1341-001349, 1341-001350, 1341-001351, 1341-001352, 1341-001353, 1341-001354, 1341-001355, 1341-001356, 1341-001357, 1341-001358, 1341-001359, 1341-001360, 1341-001361, 1341-001362, 1341-001363, 1341-001364, 1341-001365, 1341-001366, 1341-001367, 1341-001368, 1341-001369, 1341-001370, 1341-001371, , 1341-001693, 1341-001694, 1341-001695, 1341-001696, 1341-001697, 1341-001698, , 1341-000011, 1341-000012, 1341-000013, 1341-000014, 1341-000015, 1341-000016, 1341-000017, 1341-000018, 1341-000019, 1341-000020, 1341-000021, 1341-000022, 1341-000023, 1341-000024, 1341-000030, 1341-000031, 1341-000032, 1341-000033, 1341-000034, 1341-000035, 1341-000036, 1341-000037, 1341-000038, 1341-000039, 1341-000040, 1341-000041, 1341-000042, 1341-000043, 1341-000044, 1341-000045, 1341-000046, 1341-000047, 1341-000048, 1341-000049, 1341-000050, 1341-000051, 1341-000052, 1341-000053, 1341-000054, 1341-000055, 1341-000056, 1341-000057, 1341-000058, 1341-000059, 1341-000060, 1341-000061, 1341-000062, 1341-000063, 1341-000064, 1341-000065, 1341-000066, 1341-000067, 1341-000068, 1341-000069, 1341-000070, 1341-000071, 1341-000075, 1341-000076, 1341-000077, 1341-000078, 1341-000079, 1341-000448, 1341-000449, , 1341-000682, 1341-000683, 1341-000684, 1341-000685, 1341-000686, 1341-001751, 1341-001752, 1341-001753, 1341-001754, 1341-001755, , 1341-000703, 1341-000704, 1341-000705, 1341-000706, 1341-000707, 1341-000708, 1341-000709, 1341-000710, 1341-000711, 1341-000712, 1341-000713, 1341-000714, 1341-000715, 1341-000716, 1341-000717, 1341-000718, 1341-000719, 1341-000720, 1341-000721, 1341-000722, 1341-000723, 1341-000724, 1341-000725, 1341-000726, 1341-000727, 1341-000728, 1341-000729, 1341-000730, 1341-000731, 1341-000732, 1341-000733, 1341-000734, 1341-000735, 1341-001807, 1341-001808, 1341-001809, 1341-001810, 1341-001811, 1341-001812, 1341-001813, 1341-001814, 1341-001815, 1341-001816, 1341-001817, 1341-001818, 1341-001819, 1341-001820, 1341-001821, 1341-001822, 1341-001823, 1341-001824, 1341-001825, 1341-001829, 1341-001830, 1341-001831, 1341-001832, 1341-001833, 1341-001834, 1341-001835, 1341-001836, 1341-001837, 1341-001838, 1341-001839, 1341-001840, 1341-001841, 1341-001842, 1341-001843, 1341-001844, 1341-001845, 1341-001846, 1341-001847, 1341-001848, 1341-001849, 1341-001850, 1341-001851, 1341-001852, 1341-001853, 1341-001854, 1341-001855, 1341-001856, 1341-001857, 1341-001858, 1341-001859, 1341-001860, 1341-001861, 1341-001862, 1341-001863, 1341-001864, 1341-001865, 1341-001866, 1341-001867, 1341-001868, 1341-001869, 1341-001870, 1341-001871, 1341-001872, 1341-001873, 1341-001874, 1341-001875, 1341-001876, 1341-001877, 1341-001878, 1341-001879, 1341-001880, 1341-001881, 1341-001882, 1341-001883, 1341-001884, 1341-001885, 1341-011826, 1341-011827, 1341-011828, 1341-000192, 1341-000193, 1341-000194, 1341-000195, 1341-000196, 1341-000197, 1341-000198, 1341-000199, 1341-000200, 1341-000201, 1341-000202, 1341-000203, 1341-000204, 1341-000205, 1341-000206, 1341-000207, 1341-000208, 1341-000209, 1341-000210, 1341-000211, 1341-000212, 1341-000213, 1341-000214, 1341-000215, 1341-000216, 1341-000217, 1341-000218, 1341-000219, 1341-000220, 1341-000221, 1341-000222, 1341-000223, 1341-000224, 1341-000225, 1341-000226, 1341-000227, 1341-000228, 1341-000229, 1341-000230, 1341-000231, 1341-000232, 1341-000233, 1341-000925, 1341-000926, 1341-000927, 1341-000928, 1341-001992, 1341-001993, 1341-001994, 1341-001995, 1341-001997, 1341-001998, 1341-001999, 1341-002000, 1341-002001, 1341-002002, 1341-002003, 1341-002004, 1341-002005, 1341-002006, 1341-002007, 1341-002008, 1341-002009, 1341-002010, 1341-002011, 1341-002012, 1341-002013, 1341-002016, 1341-002017, 1341-002018, 1341-002019, 1341-002020, 1341-002021, 1341-002022, 1341-002023, 1341-002053, 1341-002054, 1341-002055, 1341-002056, 1341-002057, 1341-002058, 1341-002059, 1341-002060, 1341-002061, 1341-002062, 1341-002063, 1341-002064, 1341-002065, 1341-002066, 1341-002067, 1341-002068, 1341-002069, 1341-002070, 1341-002071, 1341-002072, 1341-002073, 1341-002074, 1341-002075, 1341-002076, 1341-002077, 1341-002084, 1341-002085, 1341-002086, 1341-002087, 1341-002088, 1341-002089, 1341-002090, 1341-002091, 1341-002092, 1341-002093, 1341-002094, 1341-002095, 1341-002096, 1341-002097, 1341-002098, 1341-002099, 1341-002100, 1341-002101, 1341-002102, 1341-002103, 1341-002104, 1341-002105, 1341-002106, 1341-002107, 1341-002108, 1341-002109, 1341-002110, 1341-002111, 1341-002112, 1341-002113, 1341-002114, 1341-002115, 1341-002116, 1341-002118, 1341-002119, 1341-002120, 1341-002121, 1341-002127, 1341-002128, 1341-002129, 1341-002130, 1341-002131, 1341-002132, 1341-002133, 1341-002134, 1341-002135, 1341-002136, 1341-002137, 1341-002138, 1341-002139, 1341-002140, 1341-002141, 1341-002142, 1341-002159, 1341-002160, 1341-002161, 1341-002165, 1341-002166, 1341-002167, 1341-002168, 1341-002169, 1341-002170, , 1341-000649, 1341-000650, 1341-000651, 1341-000652, 1341-000653, 1341-000654, 1341-000655, 1341-000656, 1341-000657, 1341-000658, 1341-000659, 1341-000660, 1341-000661, 1341-000662, 1341-000663, 1341-000664, 1341-000665, 1341-000666, 1341-000667, 1341-000668, 1341-000669, 1341-000670, 1341-000671, 1341-000672, 1341-000673, 1341-000674, 1341-000675, 1341-000676, 1341-000677, 1341-000678, 1341-000679, 1341-000680, 1341-000681, 1341-001060, 1341-001061, 1341-001062, 1341-001063, 1341-001064, 1341-001065, 1341-001066, 1341-001067, 1341-001068, 1341-001069, 1341-001070, 1341-001071, 1341-001072, 1341-001073, 1341-001074, 1341-001075, 1341-001076, 1341-001077, 1341-001078, 1341-001079, 1341-001080, 1341-001081, 1341-001082, , 1341-000152, 1341-000153, 1341-000154, 1341-000155, 1341-000156, 1341-000157, 1341-000158, 1341-000159, 1341-000160, 1341-000161, 1341-000162, 1341-000163, 1341-000164, 1341-000165, 1341-000166, 1341-000167, 1341-000168, 1341-000169, 1341-000170, 1341-000171, 1341-000172, 1341-000173, 1341-000174, 1341-000175, 1341-000176, 1341-000177, 1341-000178, 1341-000179, 1341-000180, 1341-000181, 1341-000182, 1341-000183, 1341-000184, 1341-000185, 1341-000186, 1341-000187, 1341-000188, 1341-000189, 1341-000190, 1341-000191, 1341-001158, 1341-001163, 1341-001164, 1341-001165, 1341-001166, 1341-001167, 1341-001168, 1341-001169, 1341-001170, 1341-001171, 1341-001172, 1341-001173, 1341-001174, 1341-001175, 1341-001176, 1341-001177, 1341-001178, 1341-001179, 1341-001180, 1341-001181, 1341-001182, 1341-001183, 1341-001184, 1341-001185, 1341-001186, 1341-001187, 1341-001188, 1341-001189, 1341-001190, 1341-001191, 1341-001192, 1341-001193, 1341-001194, 1341-001195, 1341-001196, 1341-001197, 1341-001198, 1341-001199, 1341-001200, 1341-001201, 1341-001275, 1341-001405, 1341-001406, 1341-001407, and 1341-001408
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Inc., Issaquah, WA, by letter on July 17, 2008. Firm initiated recall is ongoing.
REASON
During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.
VOLUME OF PRODUCT IN COMMERCE
2,055 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native 256Mbyte internal memory card with date code "0308. The product is used for the termination of ventricular tachycardia and ventricular fibrillation, Recall # Z-2337-2008
CODE
Serial Numbers: US00100694- US00100695 US00101003 US00101148 US00101277 US00101427 US00101443 US00101696 US00101876 US00102033 US00102552 US00102602 US00202756 US00202955 US00203505 US00203923 US00204295 US00204347 US00204361 US00204423 US00204438 US00204490 US00204648 US00205100 US00205625 US00205636 US00205650- US00205651 US00205660 US00205666 US00205688 US00205751 US00205839 US00205994 US00206144 US00206531 US00206641 US00207021 US00207313 US00207485 US00207604 US00207924 US00207930 US00208087 US00208140 US00208752 US00208789- US00208790 US00209355 US00209715 US00210183 US00210304 US00210783 US00210982 US00212242 US00212790 US00315280 US00315447 US00315464 US00316930 US00318057 US00318523 US00318538 US00319936 US00321428 US00324554 US00324581- US00324584 US00324586 US00324614- US00324616 US00324619- US00324620 US00324622 US00324624- US00324625 US00324627 US00324642 US00324645- US00324646 US00324659 US00324680 US00324707 US00324712- US00324713 US00324718 US00324720 US00324727- US00324731 US00324734 US00324736 US00324744 US00324748- US00324749 US00324751 US00324754 US00324756 US00324758- US00324761 US00324763- US00324765 US00324767- US00324769 US00324771 US00324773 US00324775 US00324777 US00324779- US00324786 US00324788- US00324789 US00324802- US00324838 US00324841- US00324845 US00324847- US00324856 US00324858- US00324929 US00324932- US00324942 US00324944 US00324947- US00324952 US00324954 US00324956- US00324959 US00324961- US00324968 US00324970- US00324971 US00324973- US00324975 US00324979- US00324980 US00324982 US00324984 US00324986 US00324997 US00325003 US00325005 US00325007- US00325008 US00325010 US00325023- US00325024 US00325028 US00325031- US00325032 US00325035 US00325038 US00325040- US00325043 US00325045 US00325048- US00325049 US00325054- US00325057 US00325062- US00325064 US00325066 US00325068- US00325069 US00325081- US00325082 US00325085- US00325087 US00325094- US00325096 US00325166 US00325231 US00325234- US00325235 US00325583- US00325587 US00325612- US00325613 US00325616 US00325621 US00325623- US00325624 US00325628 US00325651 US00325654- US00325655 US00325661- US00325664 US00325674- US00325690 US00325692 US00325694 US00325696- US00325701 US00325703- US00325726 US00325728- US00325731 US00325734- US00325742 US00325744- US00325746 US00325748- US00325755 US00325757- US00325759 US00325762- US00325763 US00325766- US00325768 US00325770- US00325771 US00325773- US00325775 US00325780- US00325781 US00325787- US00325790 US00325795- US00325797 US00325799- US00325800 US00325804 US00325806- US00325808 US00325810 US00325812- US00325814 US00325816- US00325823 US00325827- US00325828 US00325830- US00325838 US00325847- US00325848 US00325851- US00325853 US00325856 US00325858- US00325859 US00325861 US00325863 US00325867 US00325870- US00325871 US00325873- US00325875 US00325877- US00325878 US00325889 US00325903 US00325908- US00325909 US00325943 US00325957 US00325979 US00325994 US00326002 US00326008 US00326034 US00326043 US00326058 US00326061- US00326065 US00326069 US00326073- US00326075 US00326079 US00326084 US00326225 US00326248 US00326350 and US00326505
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on July 17, 2008. Firm initiated recall is ongoing.
REASON
Defective internal memory cards may exhibit one or more of the following behaviors: "Device repeatedly restarts approximately every 20 seconds "Slow device start-up of approximately 15 seconds or more. During this time, the MRx displays either a blank screen or the Philips HeartStart MRx Start-up screen prior to displaying the selected mode of operation (i.e. Monitor, AED, Pacing or Manual Defib mode). " Internal Memory Failure INOP message when attempting to print an event from the Data Management screen. "When printing from the Data Management screen, a patients Event Summary prints with some clinical events missing.
VOLUME OF PRODUCT IN COMMERCE
523 units
DISTRIBUTION
Nationwide, Canada Australia, Brazil , China, France, Germany, Great Britain, Hong Kong, Indonesia, Italy, Latvia, New Zealand, Saudi Arabia, and South Africa
___________________________________
PRODUCT
Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use, Recall # Z-2339-2008
CODE
Multiple serial numbers, starting with GRV-100: 182, 181, 178, 176, 166, 161, 160, 151, 150, 115, 110, 109, 106, 100, 099, 098, 094, 082, 081, 079, 076, 073, 064, 058, 056, 054, 053, 050, 044, 043, 041, 040, 035, 033, 021 and 013
RECALLING FIRM/MANUFACTURER
Sunrise Medical, Inc., Fresno, CA, by telephone and letters beginning on November 13, 2006. Firm initiated recall is complete.
REASON
Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide, Canada, New Zealand and Australia
___________________________________
PRODUCT
a) Exact Calcar Planer Rasp Style Blade, 38mm, REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly, Recall # Z-2370-2008;
b) Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly, Recall # Z-2371-2008;
c) Exact Calcar Planer Rasp Style Blade, 46mm; REF 31-473797. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly, Recall # Z-2372-2008;
d) Exact Calcar Planer Rasp Style Blade, 50mm; REF 31-473798. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly, Recall # Z-2373-2008
CODE
a) Lots 739370, 442250, 848550 and 904090;
b) Lots 010180, 865890, 439380, 850170 and 918020;
c) Lots 850560, 439390, 848560 and 918030;
d) Lot 834190
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON
The blades will oxidize after the first cleaning.
VOLUME OF PRODUCT IN COMMERCE
141 units
DISTRIBUTION
Nationwide and China
____________________________________
PRODUCT
a) Access and Access 2 Immunoassay System, Recall # Z-2384-2008;
b) SYNCHRON LXi 725 System, Recall # Z-2385-2008;
c) Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System, Recall # Z-2386-2008;
d) UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System, Recall # Z-2387-2008
CODE
a) and b) Peristaltic Pumps with Serial Numbers above 22349820;
c) Unicel DxC 600i with Peristaltic Pumps with Serial Numbers above 22349820; Unicel Dxl 600 Peristaltic Pumps with Serial Numbers of 22965501 and above;
d) Peristaltic Pumps with Serial Numbers of 22454201 and above
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on April 16, 2008.
Manufacturer: Beckman Coulter Inc., Fullerton, CA. Firm initiated recall is ongoing.
REASON
The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.
VOLUME OF PRODUCT IN COMMERCE
694 units
DISTRIBUTION
Nationwide, and Canada
___________________________________
PRODUCT
NicoletOne photic adapter cable 085-463700, Recall # Z-2389-2008
CODE
085-463700
RECALLING FIRM/MANUFACTURER
Cardinal Health NeuroCare Division, Madison, WI, by letter beginning June 5, 2008. Firm initiated recall is ongoing.
REASON
The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensity may fail to elicit a response from a photosensitive seizure disorder patient which may result in lack of appropriate treatment for this disorder.
VOLUME OF PRODUCT IN COMMERCE
92 units
DISTRIBUTION
CA FL GA ID IN LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico Netherlands Russia Saudi Arabia Slovenia
___________________________________
PRODUCT
a) Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder, Recall # 2390-2008;
b) Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder, Recall # Z-2391-2008;
c) Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder, Recall # Z-2392-2008;
d) Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder, Recall # Z-2393-2008;
e) Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder, Recall # Z-2394-2008
CODE
a) Lot number 7208;
b) and c) Lot number 7206;
d) Lot number 6016;
e) Lot number 7201
RECALLING FIRM/MANUFACTURER
Apogee Medical, Inc., Youngsville, NC, by letter on/about July 17, 2008 with follow-up letters, telephone and emails. Firm initiated recall is ongoing.
REASON
Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
VOLUME OF PRODUCT IN COMMERCE
23.400 devices
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments. Catalog number 530.100, Recall # Z-2395-2008
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Synthes U S A, West Chester, PA, by letters beginning on July 23, 2008.
Manufacturer: Synthes Gmbh, Oberdorf, Switzerland. Firm initiated recall is ongoing.
REASON
The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. The currently validated sterilization parameter is a minimum of 24 minutes prevacuum.
VOLUME OF PRODUCT IN COMMERCE
584 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm From Tip), Catalog No./REF 10303101. Sterile, Recall # Z-2396-2008;
b) Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From Tip), Catalog No./REF 10303102. Sterile, Recall # Z-2397-2008;
c) Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm From Tip), Catalog No./REF 10303103. Sterile, Recall # Z-2398-2008
CODE
a) Lot numbers: S08B01, S08B05, S08C02, and S08C07;
b) Lot numbers: S08B02, S08B06, S08C01, S08D02, and S08D11;
c) Lot numbers: S08B03, S08C03, S08C04, and S08C08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics, Inc., Queensbury, NY, by letters on/about July 10, 2008.
Manufacturer: Via Biomedical, Maple Grove, MN. Firm initiated recall is ongoing.
REASON
The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.
VOLUME OF PRODUCT IN COMMERCE
1,490 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box, Recall # Z-2399-2008;
b) PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL, Recall # Z-2400-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
DiaDexus, Inc., South San Francisco, CA, by email and letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON
Product may give Lp-PLA2 values at up to 22% lower than accurate values.
VOLUME OF PRODUCT IN COMMERCE
65 units
DISTRIBUTION
Nationwide, UK and Germany
___________________________________
PRODUCT
GE Voluson® E8 Ultrasound System with software versions 6.0.0, 6.0.1, 6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a qualified physician for ultrasound evaluation of Fetal OB; abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal , PV neurological), Recall # Z-2404-2008
CODE
Serial numbers: D00854 D03101 D03423 D00152 D00289 D00323 D00408 D00414 D00477 D00482 D00676 D00679 D00838 D00866 D03109 D03172 D03401 D03422 D03441 D03626 D03849 D03855 D03119 D03683 D03866 D00160 D00212 D00283 D00320 D00377 D00427 D00463 D00678 D01032 D01038 D03206 D03287 D03358 D03391 D03498 D03625 D00811 D00832 D03154 D00578 D03492 D03617 D03644 D03677 D03743 D03295 D00161 D00329 D00370 D00371 D00472 D00588 D00589 D00921 D00229 D00164 D00664 D00979 D00998 D01001 D03216 D03655 D00181 D00191 D00269 D00390 D00709 D00717 D00786 D00805 D00882 D00883 D00885 D00886 D00891 D01021 D00857 D03478 D00123 D00530 D00942 D00947 D00948 D01066 D03400 D03427 D03442 D03704 D03183 D03864 D00361 D00737 D03384 D03712 D00738 D00144 D03440 D03233 D03488 D00620 D00895 D00985 D03643 D00211 D00743 D03196 D03342 D03402 D03654 D03742 D03765 D03776 D03779 D03780 D03845 D00724 D00731 D03507 D03490 D03493 D03494 D03495 D00363 D00368 D03382 D00515 D00131 D00309 D00334 D00429 D00874 D03581 D00699 D03628 D00146 D00179 D00202 D00208 D00215 D00221 D00237 D00257 D00260 D00263 D00265 D00268 D00271 D00285 D00286 D00353 D00358 D00439 D00458 D00479 D00489 D00511 D00518 D00538 D00598 D00600 D00605 D00621 D00648 D00660 D00661 D00673 D00675 D00708 D00714 D00732 D00845 D00848 D00865 D00896 D00909 D00937 D00944 D00945 D00961 D01010 D01011 D01062 D03110 D03111 D03138 D03148 D03159 D03173 D03207 D03267 D03269 D03280 D03296 D03310 D03322 D03327 D03331 D03332 D03333 D03336 D03343 D03351 D03352 D03354 D03355 D03362 D03364 D03365 D03367 D03368 D03369 D03374 D03375 D03376 D03379 D03381 D03418 D03424 D03456 D03491 D03523 D03532 D03533 D03540 D03545 D03550 D03577 D03597 D03598 D03600 D03601 D03602 D03603 D03604 D03605 D03606 D03607 D03610 D03612 D03614 D03615 D03616 D03664 D03665 D03672 D03673 D03675 D03678 D03682 D03684 D03706 D03720 D03721 D03722 D03726 D03732 D03761 D03763 D03816 D03833 D03843 D00145 D00196 D00201 D00204 D00205 D00206 D00207 D00216 D00219 D00274 D00275 D00276 D00281 D00287 D00410 D00438 D00447 D00496 D00527 D00596 D00610 D00674 D00842 D00899 D00967 D01045 D03102 D03113 D03117 D03131 D03285 D03301 D03313 D03325 D03326 D03328 D03348 D03360 D03366 D03371 D03378 D03431 D03474 D03536 D03585 D03595 D03666 D03667 D03671 D03676 D03679 D03681 D03783 D00117 D00121 D00138 D00141 D00150 D00165 D00167 D00170 D00171 D00183 D00218 D00253 D00256 D00259 D00261 D00267 D00273 D00311 D00313 D00315 D00328 D00378 D00383 D00385 D00431 D00441 D00448 D00461 D00606 D00607 D00614 D00615 D00617 D00618 D00623 D00681 D00716 D00830 D00860 D00861 D00862 D00867 D00871 D00872 D00873 D00901 D00935 D00955 D00988 D03118 D03120 D03132 D03161 D03175 D03176 D03189 D03194 D03270 D03361 D03388 D03389 D03390 D03404 D03405 D03408 D03413 D03414 D03420 D03425 D03428 D03429 D03430 D03483 D03512 D03515 D03522 D03525 D03530 D03565 D03583 D03586 D03591 D03592 D03596 D03629 D03641 D03642 D03647 D03649 D03740 D03769 D00154 D00177 D00190 D00234 D00235 D00245 D00247 D00262 D00264 D00443 D00457 D00462 D00536 D00612 D00613 D00650 D00667 D00869 D00870 D00914 D00930 D00984 D00994 D01067 D03011 D03265 D03284 D03297 D03372 D03406 D03407 D03409 D03573 D03594 D03646 D03668 D03674 D03689 D03738 D03805 D00143 D00590 D00828 D03123 D03141 D03209 D03212 D03417 D03527 D03685 D00941 D00723 D00483 D00498 D00719 D00728 D01008 D01056 D03453 D03657 D03719 D00394 D03251 D03852 D00288 D00736 D03377 D03457 D03476 D03477 D00308 D00905 D03450 D03465 D00122 D00499 D00622 D00730 D00807 D00812 D00829 D00878 D00943 D03502 D03503 D03505 D03526 D03531 D03554 D03567 D03691 D03725 D03744 D03754 D00156 D00424 D00535 D00818 D00839 D00879 D00970 D01051 D03524 D03699 D00113 D00434 D00868 D03105 D03260 D03528 D03659 D03696 D00950 D00954 D00958 D00959 D03660 D03661 D03728 D03756 D00332 D00722 D00933 D00949 D00322 D01015 D03609 D00508 D03394 D03396 D03290 D03717 D01039 D01040 D00240 D00756 D00934 D00946 D01018 D03433 D00126 D03397 D00272 D00971 D03171 D00341 D03818 D00692 D00504 D00680 D00974 D03737 D00478 D00645 D01012 D03658 D03104 D00533 D00982 D00507 D03762 D03289 D03403 D03475 D00279 D00688 D00521 D03707 D00278 D00407 D00449 D03385 D03392 D03432 D03460 D00128 D00277 D00529 D00534 D00634 D00643 D00690 D00980 D00981 D01014 D01016 D03416 D03448 D03454 D03470 D03472 D03479 D03727 D03749 D00419 D00644 D00682 D00721 D03703 D00684 D01013 D00663 D00486 D00528 D00583 D00641 D00647 D00672 D01052 D01053 D01055 D03164 D03182 D03191 D03198 D03231 D03249 D03275 D03282 D03294 D03299 D03349 D03357 D03383 D03393 D03395 D03398 D03399 D03419 D03426 D03608 D03631 D03736 D00474 D03439 D00475 D00635 D00713 D01017 D03230 D03410 D03630 D03634 D00939 D00157 D00338 D00686 D03179 D03537 D03651 D03652 D01076 D03438 D03443 D03690 D00687 D00917 D00514 D03618 D03686 D03808 D00876 D01046 D03656 D00225 D00677 D03819 D00646 D01070 D01073 D03582 D03611 D03786 D03789 D03790 D03791 D03792 D03830 D03848 D03850 D03851 D00217 D00153 D00222 D00248 D00591 D00599 D03155 D03192 D03201 D03140 D03637 D03386 D00321 D03135 D03356 D00432 D00473 D03387 D03580 D03624 D00799 D00964 D00966 D00440 D00911 D03359 D03363 D03373 D03782 D00466 D00611 D00898 D00975 D03200 D03486 D00409 D00494 D00659 D03858 D03547 D03853 D00501 D03543 D03552 D03555 D03584 D03599 D00446 D00500 D00890 D03293 D03648 D00951 D03796 D03827 D03846 D03860 D00442 D01050 D01057 D03688 D00453 D00452 D03116 D03521 D00101 D00471 D03662 D00436 D00755 D00841 D00846 D00922 D00956 D01061 D03108 D03250 D03412 D03473 D03482 D03504 D03508 D03518 D03535 D03632 D03700 D00151 D00734 D00750 D00877 D03170 D03286 D03734 D03772 D00524 D00603 D00604 D00324 D00417 D00428 D00601 D00602 D00642 D00815 D00831 D00875 D00880 D00881 D01059 D03716 D03785 D03836 D00238 D00932 D03444 D03553 D03619 D00148 D00213 D00301 D00510 D00597 D00833 D01058 D03106 D03464 D03467 D03735 D03593 D01047 D00729 D00851 D00915 D00999 D03350 D03645 D00369 D03653 D00584 D00657 D00952 D00280 D00342 D03587 D01071 D03773 D00624 D01069 D00595 D01077 D03520 D03588 D03590 D00103 D00155 D00166 D00180 D00250 D00251 D00255 D00325 D00331 D00430 D00444 D00454 D00464 D00470 D00476 D00497 D00509 D00513 D00522 D00526 D00547 D00549 D00553 D00555 D00556 D00557 D00559 D00585 D00671 D00691 D00753 D00843 D00852 D00863 D00893 D00913 D01030 D01031 D01072 D03246 D03248 D03314 D03435 D03513 D03548 D03556 D03575 D03576 D03578 D03798 D00294 D00382 D00384 D00668 D01044 D00544 D00545 D03680 D03730 D03731 D03807 D00102 D00379 D00381 D00386 D00387 D00433 D00540 D00586 D00609 D00662 D00683 D00766 D00844 D00864 D00957 D01043 D01048 D01054 D03005 D03114 D03125 D03190 D03245 D03252 D03271 D03272 D03277 D03278 D03279 D03562 D03589 D03613 D03633 D03640 D03650 D03698 D03708 D03710 D03739 D03741 D03771 D03800 D03802 D03809 D03810 D03811 D03839 D00233 D00517 D00523 D00525 D00542 D00822 D03199 D03241 D03484 D03340 D03311 D00343 D00630 D00669 D00793 D00800 D00973 D00990 D03236 D03242 D03449 D03480 D03487 D03781 D03806 D03345 D03276 D03330 D03339 D00193 D00197 D00303 D00304 D00306 D00307 D00349 D00356 D00359 D00367 D00372 D00375 D00412 D00465 D00490 D00495 D00552 D00558 D00566 D00571 D00574 D00580 D00581 D00638 D00665 D00703 D00735 D00745 D00751 D00767 D00769 D00776 D00788 D00795 D00809 D00889 D00938 D00987 D00989 D01007 D03144 D03273 D03283 D03347 D03370 D03461 D03466 D03489 D03511 D03541 D03621 D03787 D03815 D03822 D03826 D03829 D00592 D00480 D00701 D00725 D00801 D00884 D00326 D00337 D00347 D00411 D00469 D00631 D03825 D00720 D03264 D03497 D03514 D03516 D03559 D03560 D03561 D03563 D03564 D03566 D03568 D03569 D03570 D03571 D03572 D03574 D03579 D00492 D00139 D00451 D00992 D00996 D01004 D03733 D03801 D00485 D00502 D00636 D00707 D00718 D03137 D00258 D00350 D00351 D00364 D00554 D00903 D00910 D01020 D03195 D03455 D03458 D00168 D00186 D00203 D00224 D00242 D00249 D00310 D00317 D00388 D00445 D00561 D00582 D00768 D00772 D03149 D03274 D03341 D00632 D03261 D03485 D03509 D00173 D00236 D00244 D00330 D00339 D00340 D00694 D00695 D00758 D00760 D00765 D00775 D00778 D00782 D00794 D00995 D03133 D03324 D03334 D00182 D00254 D00398 D00649 D00742 D00810 D00819 D03153 D03187 D03202 D03213 D03215 D03220 D03223 D03232 D03259 D03320 D03335 D03447 D03549 D03759 D03764 D03774 D03777 D03813 D00415 D00627 D00640 D00656 D00797 D00968 D01033 D01037 D03129 D03130 D03235 D03499 D00189 D00192 D00195 D00200 D00209 D00366 D00393 D00468 D00953 D00972 D03169 D00418 D00481 D00487 D00563 D00570 D00573 D00575 D00579 D00666 D00816 D01024 D03160 D00178 D03152 D03225 D03255 D03337 D03462 D03463 D03517 D03534 D03558 D00421 D00516 D00543 D00920 D01009 D01035 D03304 D03459 D00314 D00142 D00395 D00405 D00413 D00425 D00562 D00564 D00567 D00693 D03107 D03115 D03122 D03185 D03211 D03222 D03224 D03228 D03229 D03253 D03256 D03298 D03309 D03338 D03353 D03380 D03415 D03446 D03451 D03452 D03755 D03799 D03803 D03812 D00300 D00158 D00344 D00352 D00397 D00403 D00460 D00541 D00548 D00888 D00892 D00894 D03240 D03436 D03437 D03821 D00176 D00316 D00423 D00435 D00791 D00826 D00897 D00912 D03145 D03214 D03346 D00711 D00712 D00726 D00727 D00887 D00228 D00246 D00302 D00399 D00493 D00653 D00655 D00963 D00978 D00336 D00392 D00420 D00422 D00625 D00633 D00639 D00652 D00763 D00813 D00993 D03126 D03162 D03167 D03227 D03254 D03288 D03300 D03344 D03820 D00293 D00346 D00503 D00512 D00531 D00546 D00565 D00741 D00749 D00752 D03157 D03165 D03268 D03748 D03751 D03775 D01019 D03219 D00977 D00292 D00296 D03147 D03234 D03302 D03421 D03501 D00568 D00577 D00923 D00931 D00936 D03136 D03197 D03217 D03218 D03221 D03243 D03308 D03316 D03318 D03321 D03329 D03500 D03551 D03622 D03623 D00108 D03747 D03750 D03752 D00685 D00696 D00733 D00777 D00781 D00787 D00789 D03319 D03323 D03445 D03510 D00223 D00239 D00241 D00282 D00629 D00790 D01034 D01036 D03814 D00199 D00214 D00220 D00318 D00373 D00705 D00770 D00774 D00780 D00825 D00908 D00919 D00927 D00194 D00357 D00484 D00537 D00539 D00616 D00628 D00651 D00698 D00702 D00740 D00744 D00771 D00773 D00779 D00783 D00784 D00785 D00792 D00821 D00960 D00962 D01000 D01002 D01005 D01006 D01025 D01027 D03184 D03186 D03237 D03266 D03291 D03317 D03542 D03620 D03638 D03768 D03784 D01023 D01026 D01028 D01029 D03193 D00134 D00243 D00626 D00654 D00670 D00739 D00747 D00748 D03128 D03139 D03146 D03150 D03151 D03158 D03168 D03174 D03178 D03180 D03238 D03257 D03258 D03262 D03263 D03292 D03305 D03306 D03434 D03496 D03538 D03757 D03760 D03767 D00455 D00467 D03778 D00230 D00231 D00762 D00764 D00983 D01003 D01022 D03127 D03797 D03823 D03824 D00105 D00127 D00132 D00135 D00136 D00185 D00187 D00335 D00355 D00532 D00569 D00572 D00576 D00700 D00710 D00746 D00754 D00759 D00761 D00806 D00820 D00840 D00847 D00850 D00858 D00906 D00907 D00918 D00928 D00986 D01042 D01060 D01074 D01075 D03281 D03312 D03315 D03471 D03481 D03506 D03519 D03539 D03544 D03546 D03714 D03746 D00227 D00991 D00997 D03203 D03303 D00658 D00107 D00114 D00163 D00175 D00184 D00188 D00198 D00210 D00226 D00232 D00252 D00291 D00295 D00297 D00299 D00305 D00312 D00319 D00327 D00333 D00345 D00354 D00362 D00389 D00391 D00396 D00400 D00402 D00404 D00406 D00450 D00459 D00491 D00506 D00550 D00551 D00560 D00697 D00704 D00706 D00798 D00802 D00803 D00804 D00814 D00817 D00824 D00835 D00900 D00904 D00924 D00925 D00926 D00929 D00969 D03103 D03134 D03142 D03156 D03163 D03166 D03177 D03188 D03205 D03208 D03210 D03226 D03411 D03529 D03557 D03627 D03635 D03636 D03639 D03663 D03669 D03670 D03687 D03693 D03694 D03697 D03701 D03705 D03709 D03711 D03713 D03718 D03723 D03729 D03745 D03753 D03758 D03766 D03770 D03788 D03817 D00855 D01041 D00426 D00519 D00593 D00856 D00859 D03468 D03469, and D03869
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, by letter dated April 1, 2008.
Manufacturer: GE Medical Systems, Kretziechnik GmbH & Co OHG, Zipf, Austria. Firm initiated recall is ongoing.
REASON
Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson® E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
1,637 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative determination of Acetaminophen concentration in human serum or plasma. Recall # Z-2405-2008
CODE
Lot numbers: M703276 and M702524
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters beginning on July 21, 2008.
Manufacturer: Beckman Coulter, Inc., Fullerton, CA. Firm initiated recall is ongoing.
REASON
Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin.
VOLUME OF PRODUCT IN COMMERCE
7,764 set kits
DISTRIBUTION
Nationwide and Canada
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PRODUCT
ACIST" BRACCO, AT P54 AngioTouch Kit, SKU # 014644, Sterile. Made in Mexico. Catalogue No: 800608-013 intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures, Recall # Z-2406-2008
CODE
Lot numbers: 0368H, 0368J, 0378L, 0388F, 0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T, 0848K, 0848L, 0878M, and 0918N
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acist Medical Systems, Eden Prairie, MN, by letters dated July 9. 2008.
Manufacturer: Nypro Healthcare Baja, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.
VOLUME OF PRODUCT IN COMMERCE
33,980 kits
DISTRIBUTION
Nationwide, Canada, Brazil, Japan, China, Korea, Thailand, Hong Kong, and Australia
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PRODUCT
a) Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System, Recall # Z-2407-2008;
b) Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System, Recall # Z-2408-2008;
c) Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System, Recall # Z-2409-2008;
d) Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System, Recall # Z-2410-2008;
e) Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk), Recall # Z-2411-2008;
f) Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk), Recall # Z-2412-2008;
g) Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set. Item/Catalog number 375059. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk), Recall # Z-2413-2008;
h) Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk), Recall # Z-2414-2008
CODE
a) Lot numbers 60999552 exp 4/30/2011, 00VL986720 exp 1/31/2013, 00VL986732
exp 1/31/2013, and 60999551 exp 3/31/2013;
b) Lot number 60998897 exp 3/31/2013;
c) Lot number 60998903 exp 3/31/2013;
d) Lot number 60998893 exp 3/31/2011;
e) Lot number 60999539 exp 3/31/2013;
f) Lot number 60999546 exp 3/31/2013;
g) Lot number 60999544 exp 3/31/2013;
h) Lot number 00VL987139 exp 12/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter dated June 20, 2008.
Manufacturer: B. Braun, Santo Domingosanto Domingo, Dominican Republic. Firm initiated recall is ongoing.
REASON
Incorrect burette was packaged with the product.
VOLUME OF PRODUCT IN COMMERCE
29,180 units
DISTRIBUTION
Nationwide
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PRODUCT
Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560). The equipment is intended for transferring lifts from one system track to another. Recall # Z-2434-2008
CODE
Serial numbers: GA-1304-0001 to GA-2608-1374, all units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated August 1, 2008.
Manufacturer: B.H.M. Medical, Inc., Magog, Canada. Firm initiated recall is ongoing.
REASON
There is a possibility that the Kwiktrak Gate System could malfunction, resulting in the gate locks opening even though the corresponding tracks are not properly aligned.
VOLUME OF PRODUCT IN COMMERCE
230 units
DISTRIBUTION
Nationwide
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PRODUCT
a) Innova 2000; The principle system components include a C-arm, image acquisition, processing and archiving capabilities. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology, Recall # Z-2435-2008;
b) Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology, Recall # Z-2436-2008;
c) Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology, Recall # Z-2437-2008;
d) Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology, Recall # Z-2438-2008
CODE
a) Lot numbers: 201996LAB2 201996LAB3 202745VACATH2 203576NI1 205783BCL3 205783BCL4 206598INNOVA1 207626CL1 207755CL1 207795CL1 207795CL2 207871CL6 208381INNOVA 208523CATH 209526ICATH1 210292CATH1 210297NECATH1 212746J412 213726CATH 213977INNOVA1 213977INNOVA4 214320INNOVA 214590INNOVA 214820INNOVA3 214820INNOVA4 214947CMINNOVA 215448INNOVA 215728INNOVA 215861LC2 216778LABA 217258CATH 217383CCL3A 217464INNOVA 219465CL1 219465EP 219757INVA 219932DCL1 219947EP 228INNOVA 229259INOV1 229259INOV2 229386INOV1 239436CATH2 239939CLB 251435ICV1 251435ICV4 252443NGIN1 253627INNOVA2 253627INNOVA3 254519I2K 256341IN1 256386IN1 256880IN1 262243INNOVA1 262255INNOVA1 262569INNOVA 281338INA 281351TINNOVA 281440LAB2 281440LAB3 281540NECATH 281893INNOVA 301891CATH1 302421INNOVA 303320CL1 303320CL2 303369CL2 303425HCL1 303673CL1 303715CL1 303730CL1 303778CL1 303778CL2 305223IN1 305223IN2 305325CCL3 305325CL4 305585CL2 305585CL3 308865PHI 309454BINNOVA 309691HCL1 309691PINNOVA 310423INNOVA3 310423INNOVA4 310423INNOVA5 310423INNOVA7 310540INNOVA 312792RINOV2 313343LC 314569JC1 314966DCL2A 315448RM1 315448RM2 315448RM3 316268INNOVAB 316268INNOVAEP 316689INNOVA1 317621EP2 317621INNOVA1 317621INNOVA2 317621INNOVA3 317818MDI915 317887INNOVA1 317887INNOVA2 318448INNOVA 318449INNOVA1 321HCL4 321HCL5 321PBCL1 330375LAB1 330837INNOVA 336716BCL1 336832MCCL1 336832MCCL3 337289INNOVA 352344CATH1 352INVCATH 361788NOVA 386719CATH 401274IN3 402280CIN1 402280CIN2 404265AMC2 404305SF1 404686CRI1 404686CRI2 404712EI1 405272SCL4 407321INCL1 407518CL1 407518OPCL 408259INV 410337INNOVA1 410337INNOVA3 410337INNOVA4 410337INNOVA5 410543CATH1 410543CATH6 410614CV7 412232B 412367LAB1 412367LAB3 412623LABB 412623LABC 412623LABI 412647LABA 412647LABB 412647LABC 412647LABD 412784C1 413748INNOVA 414219INNOVA 414291CL3 414649INNOVA 414805INNOVA2 414961INNOVA 415206CATH 415750SCL1 415750SCL2 416284INNOVA 416469INNOVA 417269SCLB 417269SCLC 417885JCL1 417885JCL2 417885JCL3 417885JCL4 418656CNOVA1 418656CNOVA2 419227CL3 419526INNOVA3 419526INNOVA4 423493PCL3 423495CHIRM1 423559BCL1 423844CCL2 440835INNOVA 443481INOVA1 443849INNOVA 478765CTH1 478765CTH2 480512IN1 480512IN3 480728LAB1 480821IN1 501484LC3 501686UAINNOVA 502587L2 502587LAB3 502587LAB5 503215INNOVA 503370INNOVA 504391INNOVA 504447INNOVA 504903INNOVA 505983CATH 508798INC2 508856IN3 508856IN4 508856IN5 508856IN6 509473DR5 509473DR6 509473DR7 509946CATH1 512341RI 512447SI 512447SI2 513559INNOVA 513853INNOVA 513861INNOVA 514376CARDIO 514468BINNOVA 514843AINNOVA 516562INNOVA3 516562INNOVA5 516663EP3 516663INNOVA1 518243EP1 518525LAB2 519663INNOVA 520296CATH1 530244XC3 540932INNOVA 541282CV1 541382CV1 541382CV2 541686SPR3 561548CL1 561548CL2 561548EP 561798CATH1 561798CL1 562491INNOVA 563244CATHLAB1 563244CATHLAB2 563421CATHLAB1 563421CATHLAB2 563421CATHLAB4 563421CATHLAB7 570969CATH 573472CATH 573632CRC1 573686CL1 573761SMC1 601268INNOVA1 601553CL1 601553CL2 601968INNOVA 602239LAB1 602588INNOVA 603228CCL2 603433PLC1 603650CATH3 603668CLCB 604682INNOVA 605719INNOVA1 605719INNOVA2 606439INNOVA 608324CATH 609267INNOVA 609652CATH2 609653INNOVA 609757IN2000 610270INNOVA 610431CL1 610431CL2 610447CL2 610645CL5 610648INNOVA 610954INNOVA 610954INNOVA2 610988INNOVA1 610988INNOVA2 610988INNOVA3 612273INNOVA1 612467INNOVA1 613548INNOVA2 614293INNOVA1 614293INNOVA2 614293INNOVA3 615222STCL3 615222STCL5 615284CV2 615316INOV2 615327CV1 615327CV2 615495MCL5 615768CV1 617754IN1 617754IN2 617754IN3 617754IN4 618241GSI 619260INNOVA 619340VA7 619457INNOVA3 619691INNOVA 619739INNOVA 623848LAB1 626915INNOVA 631376INNOVA 636916SPCL1 636947JCL3 650696INV1 650723SC6 651582INN1 661949INNOVA 701234GE2 701234GE3 701857I2K 702388INNOVA1 702564INNOVA 702731INNOVA 702731INNOVA2 702731INNOVA3 704487CMIN1 706651CCL 706721CCL 706774CCL2 706774UC6 707546INNOVA 708202VA2K 708333INOVA 708352L2K 708425INNOVA1 708597EP 713359INA 713359INB 713776MINNOVA 713794LAB10 713794LAB3 713794LAB4 713897CIN 713964BIN 714229INNOVA 714533INNOVA 714953INNOVA 714999INNOVA 716859BGEP 717270INNOVA1 717270INNOVA2 717544CATH1 717544CATH4 717763INNOVA 717763INNOVA2 717782INNOVA 718226INNOVA1 718226INNOVA2 718283INNOVA1 718283INNOVA2 718780CATH1 718918CATH1 718963INNOVA1 719560HCL2 719776CL1 719776CL2 720225CL1 724284CL 724773C2 724773C3 727521CATH3 727725CATH1 727825CATH 727869CATH1 732557INNOVA 732776CATH1 732776CATH5 740439CATH 740454INNOVA1 740454INNOVA2 757886CATH1 760633INNOVA 760940INNOVA1 770228GC1 770991INNOVA 773702INNOVA 773878SWGCATH1 773878SWGCATH2 773878WCL 773884HC2000 773STJINNOVA200 775770CATH1 775982CATH3 785354HRT1 785354HRT2 801299INNOVA 801373CATH1 801373CATH2 801373EP 801429INNOVA 801479INNOVA 803256CL6 803256PCL3 803256PEP1 803256PEP3 803329CL20 803641CCL 804285CATH4 804320CATH1A 804320CATH3A 804320CATH5 804320CATH6 804764INNOVA 805497INNOVA1 805497INNOVA2 806354INNOVA1 806354INNOVA2 808242INNOVA 812265L1 812283IN20 812376CL1 812450CATH2 813615CL2 814534C1 814765CATH 815226INN1 816932HRT2 816932SLHEART8 816985NKCI2 817255NH2000 817329BGINNOVA 817347MPINNOVA 817465ARINNOVA 817877INNOVA 817922INNOVA 818502INNOVA1 819563CINNOVA1 819563CINNOVA2 828262CL 828298CCL 828322FIN 831462CL1 831624INV1 832355SMIN 843339INNOVA 843577CL1 843674INNOVA 843692INNO 850325INNOVA1 850325INNOVA2 850494INNOVA 850494INNOVA2 850862INNOVA1 850862INNOVA2 856342INNOVA 859233INNOVA1 859233INNOVA2 859276INNOVA 859313CL6 859313CL7 860210CV 860358CV 861EP2 864261CL1 864261CL2 864455GMIN1 864455GMIN2 865218CCL1 865481CCL1 865541CCL1 865541CCL2 865541CCL4 865693CCL5 870508LAB3 901384CV3 901726R2 901757CV2 901765CV1 903315INN 903798WINN 903870INN 904202CATH1 904202CATH2 905895INNOVA1 905895INNOVA2 905895INNOVA3 908668INNOVA 909865INNOVA1 909865INNOVA2 909CH2000 910343NHIN2 913317SLSHEART1 913791OINCATH 918307SHIN1 918307SHIN2 918341CI 918494IN2A 918744JI1 918744JI2 918744JI3 919934JCL 920288CATH1 920288CATH2 920729INNOVA 920738INNOVA 920926CATH1 928639IN1 936266CL2 936539CL2 937208INNOVA1 940384INNOVA2 940764INOV1 940764INOV2 940764INOV3 940898INN 941483INNOVA1 941483INNOVA2 949753INNOVA 952993INNOVA 952993INNOVA3 952993INNOVA4 956389INNOVA 956632INOVA 970350CL3 972335INN 972394INNOVA 972540INN 972969INNOVA 973365CATH 973365LAB1 973971EP2 973971LAB1 973971LAB2 973971LAB4 973971LAB5 973972LAB1 973972LAB2 973972LAB3 985867INNOVA1 985882INNOVA AL9INNOVAVAN CSI214 DR2000 DUCK ECXV1401A ECXV1406C FHORLCL2 FHORLCL4 FHORLCL5 FHORLCL6 FHVIN2000 FLGRCATH1 FLGRCATH2 FWCL3772 KMCINNOVA LIJ016133 LVEPINOV5 LVINOV1 LVINOV2 LVINOV3 MCTH072 MCTHSC1 MCTHSC2 MOUSE WCATHLAB2000 2548244 2577797 2590608 0002733004A 920020937 0920020937A 0920020937B 202745GEMNET 262548INNOVA 604875INNGEC 631968EP1 843577CL1GP, and ECXV1407I;
b) Lot numbers: 201447LAB1 202782LABC 2035762100 208227CATH1 208367INNOVA 208381CCL1 212305CATH1 212604INNOVA1 214947MINNOVA 214947MINNOVA2 215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3 251435ICV7 252384CATH1 253627INNOVA1 262255INNOVA2 262687CL2 303369HCL4 303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1 310825INNOVA21 317355INNOVA3 318448INNOVA3 330363LAB3 330375LAB2 336538ARCL 336832MCCL6 360456XCL4 402559UCC 402559UCD 405604D2100 408559INV1 409938INV21 410337INNOVA6 410554INNOVA1 410554INNOVA2 410554INNOVA3 410554INNOVA4 4107872100 412367LAB2 414291CL2 414649INNOVA2 416480INNOVA 416864INNOVA 416864INNOVA2 417269SCLA 417347FCV2 417347FCV4 423495MCATH1 4436432100 501257VALAB1 505848CATH1 505848EP 508335INNOVA 508856IN21 508941IN21 509575YM2100 516562INNOVA2A 516562INNOVA6 516562INNOVA7 516632INNOVA1 518243LAB1 518243LAB2 541732CV2 541743CL3 561548ET2 570476INNOVA21 573256MHC 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 604682INNOVA1 604682INNOVA2 604875AINNOVA1 604875AINNOVA2 607737CL1 608775NOVA1 608775NOVA2 610250INNOVA1 610250INNOVA3 610776INNOVA21 610983INNOVA2 612273INNOVA2 615284CV3 615342CV3 615446CV1 615515OPCL 617636CL1 619457INNOVA6 619552INNOVA2 630856H2100 650369SV4 65049321 651582IN3 661327INNOVA1 661327INNOVA2 7023602100 704384CL21 706291CLIN1 713375U2100 713794LAB1 717217INN21 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727521CATH2 727521CATHOP 727869CATH3 727869CCL2 727869EP5 727942CATH2 732324INN1 732776CATH4 732923INN 770HMCCL1 775982INN2100 781340IN1 781340IN3 785354HRTEP 803256PCL5 804764CATH2 8053702100 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 8157412100 815759CARDIAC1 816861KCVAI2 817329BG2100 8184092100 828213IN21 843692CATH3 843724CL1 843724CL2 843724CL3 843724EP1 843797EP 843797TCL1 845365V13 845368LAB1 845368LAB2 847316INNOVA1 847316INNOVA2 856853IN2100 857307IN421 858554INNOVA2 858554INNOVA3 864255SFCL1 864255SFCL2 865693CCL 865693CCL2 865977CCL 901765EP 904597CATH 905848INNOVA1 910343EP1 910343EP2 910671INOV21 916781INNOVA2 9284532100 937208INNOVA2 949250I21 954735CL2 954987CCL7 954987CCL8 954987CL4 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP LVINOV7 PRESBYDEP RPINNOVA2100 2637041 2680771 2683172 2686112 2706718 2710562 2713664 2713687 2715023 2718602 2729712 2730402 2730405 2730406 2731313 2731570 2731573 2731583 2738012 2741780 2749861 2754702 2755150 2756171 262687CL1 316689MP 541677MINNOVA2 541789CV1 609267IN2100 609757IN2100 610645LAB10 760940INNOVA2, and 828315FIN2;
c) Lot numbers: 2652143 2014183100 201541LAB2 201996LAB1 2035763100 2035763100A 2036883100 205783BCL5 205877CCL1 205877CCL2 207351YCL1 207662CL4 207879CL131 208227CATH2 209334LINNOVA1 214324INNOVA2 214590PH3100 215335INNOVA1 215576INNOVA1 219326IN31 2197573100 219877IN2 219877IN31 228818VASC 239436CATH3 239513CRLAB1 239939CLA 251435ICV6 251633PROV 253968INNOVA 254742KDCL1 262687CL3 270688INN 281420LAB1 281420LAB23100 281440CL3 3027443100 303425CL4 303629CL4 303629EP 303788CL2 305364P3100 308865GIN2 309691P3100 310319SM3100 310423INNOVA1 310825INNOVA31 312STMNAZ3100 313593IC1 313593IC2 314525STACL2 314768SMCL1A 314768SMCL3 316268INNOVAA 316651INNOVA31 316962WCVC1 316962WCVC2 318448INNOVA2 318449INNOVA2 318798CL1 325428CATH1 325428CATH3 334418CL 336832MCPV 337374INNOVA 352333CATH1 352333CATH2 360456XCL3 361857CATH1 361980INNOVA2 402559UCB 404686CRI3 405272SCL2 405372S3100 405604D3100 405610NW3100 405840OIC3100 406447VAIN3 406543IN3 409899LAB3 4103323100 4103623100 412437INNOVA 413447CATH 413540IN1 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417269SCLD 417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 479441SP3100 480728LAB2 480821IN2 502587LAB1 502587LAB4 502852INNOVA 5033703100 5034353100 507385INN3100 508856IN2 508941IN1 509946CATH2 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516632INNOVA2 516663INNOVA1A 516663INNOVA2 518525LAB1 530244XC106 540953INNOVA 541382CV3 541677MINNOVA1 541743CL6 541MWHINNOVA 561266IN31 561548CL4 570476INNOVA31 573458CL1 573632CRC2 573815BCR1 573882UMC1 580548B3100 6012883100CV2 601553CL3 601883CL1 602239LAB4 602239LAB6 602266LAB2 603421PCL 603580ECL1 608524NOVA 609757IN3100 610447CL1 610526LAB1 610526LAB2 610595CL1 6106483100 610770INNOVA31 610891CL1 610954INNOVA1 610983INNOVA1 615338CV2 615769SKYCV2 616392INNOVA 617732IN9 617789IN1 618241GSI3100 619340VA8 619457INNOVA5 619482INNOVA1 619541INNOVA31 619552INNOVA1 620225INNOVA31 630312B31 630856H31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 65049331 6619483100 662377CV2 662377CV4 671GMHAINVA 678957INNOVA 7018573100 7022333100 702616INNOVA 7028533100 7028803100A 704355RM2 704384CATH2 704384PHMCATH 704878CL31 706481CCL 706774CCL4 706774CCL5 7083333100 708WESTSUB3100 713359INC 713776M3100 713794LAB7 713794LAB9 713948INA 714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31A 717782INNOVA31B 718245UNITY 718250CATH1 718270INNOVA1 718283INNOVA3 718470INNOVA2 718780CATH2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV 732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1 770991CL3 772LWCL1 773792CL3100 773NORWG3100 775982CATH2 781340IN2 785354S3100 8014793100 8019643100 803255CL1 803256PCL1 803329CL31 804285CATH1 8053703100 808547QCV2A 812238LIB1 812283IN31 812450CATH1 812450EP1 812482INNOVA 812858GWLAB1 812858GWLAB2 814676C1 815226INN2 815344CARDIAC3 815599FHN3100 8157413100 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816969LSCATH 816985NKCI 817433HSW3100 8184093100 8185023100 8189813100 843797TCL2 845365V19 847362CONCATH4 850469BCV1 850678IN3100 850747BR3100 850747GC3100 850862IN3100 856596IN3100 8613100 863687CL31 864255SFCL3 865481CCL2 865512CL3 865693CCL1 901516R3 903UT3100 904202CATH3 904276CTH1 907562CATH1 908522LAB1 909464IN3 909788INNOVA1 909825VAINNOVA 910343NHIN4 912486CATH1 913345MI1 916781INNOVA1 918333JPIN1 918333JPIN2 918494IN31A 919731WMINOV 919784REP1 9202623100 925779INNOVA408 928779INNOVA1 931459CV1 936266CL1 940626DCH3100 941798CLAB2 951788INNOVA2 951788INNOVA3 952993INNOVA5 954987CCL9 956389INN31 956698INN31 956994INN1 956994INN2 970350CL1 970945CL1 9734293100 973877LAB4 973971LAB3 BPINNOVA1 BPINNOVA2 BPINNOVA3R DR3100 ECXV1406B FHORLCL1 FHORLCL7 LVINOV4 MARTINSVILLE310 MCDCATH2 2575081 2601648 2610213 2625271 2638199 2652070 2656470 2661770 2680614 2681424 2682930 2686429 2698717 2699058 2713223 2713498 2713501 2713606 2716215 2724811 2725165 2727031 2728632 2729012 2729039 2730996 2731216 2731616 2732637 2739644 2741814 2742714 2745812 2745843 2745917 2749863 2750261 2751926 2752431 2753571 2753701 2754912 2754940 2754953 2754989 2755128 443481LCV 504447INNOVA2 580421V3100 609267IN3100 609597IN3100 610645LAB6 732776CATH2, and 909CH3100;
d) Lot numbers: 201541SP1 2035764100 204787INNOVA1 205759CL2 209467INNOVA308 216844INNOVA 219326IN41 2194654100 229228INNOV41C 229228INNOV41V 22925941V 22925941V2 229434INNOV 239436CATH1 239939INNOVA 248849SP1 250370INNOVA 251435I12 251435ICV5 252816INNOVA 252847PRS2 252847PRS3 269226IN1 269226IN2 269983IN41 281401T4100 3016094100 3018774100 3027444100 303320OR41 303399IR 303436ANGIO 303839CL1 304255INNOVA 304256INNOVA 304347INNOVA 304347INNOVA2 304424CCINOVA 305823IN4100 305835IN41 306766INNOVA 308534ANG 309343CSP1A 309655FSP1A 309655FSP3A 309672M4100 312792R4100 313343SP1 313876SP41 314569SJRM12 314966DPHSP 315448RM4 315448RM5 316651INNOVA41 316962INNOVA41 317338PV3 317887INNOVAPV 3184734100 319338VA4100 325670CATH 330489SPEC9 334286BSP 337981INNOVA 352333INVOR 352333VASC 352376SP 352401CATH 352401VASC 352596SPEC 360754INNOVA 386254HS1 386254HS2 386HPOS1 401274IN41 404466SF41A 404616INNOVA 404GHSIR1 404GHSIR2 407518SP2 407518SP3 407SPECIALS 4082594100 409212INOV41 4103374100 410337INNOVA2 4105434100 412623LAB1 412623LAB3 412647OR10 412784LAB1 412784LAB2 4134474100 4135344100 4137484100 414328INN4100 414649CL2 414649DVI 414961INN4100 4163694100 416756INNOVA 419251LAB1 419557ORLAB 419696LAB1 423493I4100 423495ENDO2 423495M4100E 423495MSPEC2 4438494100 478633INOV 478765ANG1 480512SP 5033704100 505848CATH2 505848V4100 508383IN4100 508650IN41 508856OR41 5094744100 509474SH41 509482HFI 509575YM4100 512528CPCL1 512901NI4100 5134754100 5135844100 5136864100 5138534100 514376INNOVA 514842AINNOVA 514934BANGIO 515263IL4100 516562INNOVA4 519663INNOVA2 519685INNOVA 530888ANG206 541282CV2 541686SPR1 5417684100 561548VAS2 561694IN1 561747IN4 561776IN41 561784INSP 5703214100 570321LAB2 5705224100 573632CRA 573761SMA 574294IN41 574535IN41 574647IN2 574647IN41 586573SP1 6012884100SP1 601376SP4100 6029234100 603650ANG1 604557INNOVA 605333RM10 606833INNOVA 6082634100 608263ACT 608263XMR 608324DAL 609652CATH3 610954INNOVA41 610988INNOVA4 613548INNOVA3 614293LIBERTY1 614293LIBERTY2 615284OR15 617525IN1 617636IN1 617726RF2Y6 618549CM4100 619229INNOVA1 620665INNOVA41 623848SP 626359INNOVA 630275G41 630275G41B 6309784100 650369SV5 650493ANGIOCT 6616324100 662244GTSP 678EJCIR1 7023604100 7028804100 704487CR41 706278INNOVA1 706291RINN 706291RINN2 706651SP1 706733SP1 706774USP3 706802FINN 708202VA41 7087564100 708783CL4100 708783SP4100 708WESTSUB4100 713375U4100 7137764100 715369INN4100 717763INNOVA41 717763OR4100 718206LIBERTY1 718250ANGIO 718518CVL1 718630LIBERTY 719560INN41 724656ANG 727398SPEC1 727725SPEC1 727791INNOVA 727819SPSC 740592INNOVA 757398INNOVA 757736INNOVA 757889INNOVA 760633IR1 770535N4100 770736SP1 773878SWGANGIO1 77573841 801268INNOVA 80140841 8014794100 80158241 80180741 802295VALCA 803256SP 803329CL41 804285CATH2 804320CATH2B 804594ANGIO 804594CATH 804764CATH3 810342A41 812238UN41 812279INNOVA1 812825INNOVA1 812858GWSP 813558INTV 813615CL10 813745INTV 813972INTV 815740SC4100 8159374100 816276SP1 816943SP1 817255NH4100 817433HSW4100 817465AR4100 817922BA4100 828298VASC 828696IN41 843577CL2 843674VAS1 843797TIR2 845368RM10 8458584100 847842GS4100 850494WSP1 850747IN4100 856365ANGIO 8593134100 8595724100 863687INV24 864255SF4100 864573LAB2 865373SP 865481SUR 865541CCL5 865693CCL3 901726SP2 903CSM4100 903GS4100 904202SP1 904276SP 904BSSP 908522SP1 913317SLS4100 915577SP1 918307SHIN4 918682IN41 918744JC4100 918744JR4100 9408984100 941483INNOVA41 952993INNOVA2 954MW4100 956632INN4100 970247INNOVA 972335LIB 972487ANGIO1 972566INNOVA3 985867INNOVA2 989466INNOVA COR359867 DR4100 ECXV1406E ECXVINNOVARST3 FHORL4100 FWANG3217 MCL4100 MIRAMAR41 PEMBROKE4100 RADNETXV1 RADNETXV2 RHD4100 SLIN4100 WCATHLAB41 2515139 0002520549A 2574392 2650620 2667650 2670537 2677299 2680596 2683976 2697900 2698692 2701519 2705539 2710199 2712110 2712111 2713221 2718141 2722283 2729637 2730844 2733412 2733723 2740431 2741400 2741459 2741764 2742712 2742719 2743706 2744276 2744293 2744745 2745129 2745685 2745844 2746655 2750142 2750583 2753604 2754920 2756873 2757398 256429SV1 317621PV 318681INNOVA1 6012884100SUR 609757IN4100 731541XA1 904202SP2 906485ANGIO ECXVINNOVARST1 ECXVINNOVARST2, and ECXVINNOVARST4
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter dated July 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
The charger and/or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.
VOLUME OF PRODUCT IN COMMERCE
1,573 units
DISTRIBUTION
Nationwide and Guam
___________________________________
PRODUCT
a) 500 mL InfoV.A.C. Canisters (with Gel); 1) Part #M8275063/5 (5 canister pack) and 2) Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE, Recall # Z-2439-2008;
b) 500 mL InfoV.A.C. Canister (without Gel); 1) Part #M8275071/5 (5 canister pack) and 2) Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE, Recall # Z-2440-2008
CODE
a) 1) 20064392, 20069119, 20069125, 20069126, 20069279, 20069279.18308F, 20075082, and 20079173; 2) 20046268, 20046268.18908A, 20046270, 20063933, 20064393, 20064394, 20064395, 20064753, 20064753.14408B, 20067300, 20067300.14408B, 20067301, 20067302, 20067303, 20067304, 20067305, 20069120, 20069121, 20069273, 20069273.14408B; 20069274, 20069275, 20069275.18908A, 20069277, 20069277.18908A, 20069278, 20069278.18908A, 20069280, 20075084, 20075085, 20075086, 20075262, 20075263, 20075264, 20075265, 20075266, 20075268, 20075269, 20079174, 20079175, 20079176, 20079177, 20079178, 20079179, 20079180, 20079181, 20079182, 20079183, 20079184, 20079185, 20079186, 20079187, 20079188, 20089680, 20089681, 20089682, 20089712, 20089713, 20089749, 20089750, 20093372, 20093374, and 20094200;
b) 1) 20063928; 2) 20062500, 20063927, 20063927.15108D, 20063930, 20063930.15108D, 20067296, 20067297, 20067298, 20069122, 20069123, 20069123.15108D, 20069124, 20069124.15108D, 20069276, 20071227, 20073941, 20075083, 20075267, 20079189, 20079190, 20079191, 20089714, and 20094198
RECALLING FIRM/MANUFACTURER
Recalling Firm: KCI USA, Inc., San Antonio, TX, by letters on July 29, 2008
Manufacturer: Avail State College, Bellefonte, PA. Firm initiated recall is ongoing.
REASON
The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.
VOLUME OF PRODUCT IN COMMERCE
229,400 canisters
DISTRIBUTION
Nationwide, Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK
___________________________________
PRODUCT
MONARCH® II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***for AcrySof® IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use, Recall # Z-2441-2008
CODE
Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and Lot 174244 Exp 07/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Laboratories, Inc., Fort Worth, TX, by letter on July 7, 2008.
Manufacturer: Alcon Manufacturing Ltd., Huntington, WV. Firm initiated recall is ongoing.
REASON
Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
VOLUME OF PRODUCT IN COMMERCE
7,962 units
DISTRIBUTION
Nationwide, Brazil, Canada, Chile, Hong Kong, Singapore and India
___________________________________
PRODUCT
a) SERVO-i Ventilator System. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Article number 64 87 800, Recall # Z-2442-2008;
b) SERVO-s Ventilator System. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Article Number: 66-40-440, Recall # Z-2443-2008
CODE
a) Serial numbers: 34034, 34035, 34050, 34052, 34053, 34054, 34058, 34060 through 34083, 34085, 34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295, 34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230, 34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360, 34376, 34384, 34390, 34427, 34490, and 34530;
b) Serial numbers: 7591, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7613 through 7666, 7676, 7677, 7678, 7879, 7680, 7681, 7682, 7686 through 7703, 7709 through 7724, 7737, 7740, 7745, 7749, 7750, 7758, 7759, 7760, 7763, 7764, 7770, 7771, 7772, 7775, 7776, 7777, 7778, 7779, 7800 through 7825
RECALLING FIRM/MANUFACTURER
Recalling Firm: MAQUET Inc., Bridgewater, NJ, by letter on July 7, 2008.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
VOLUME OF PRODUCT IN COMMERCE
404 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Quicklock Tracker, Size 2; ref: 111.100. Device is a surgical instrument, Recall # Z-2444-2008
CODE
Lot numbers: PC040050, PC030403, PC040292, PC040293, PC050034, PC050129 and PC050034-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by telephone and e-mail on/about April 27, 2006.
Manufacturer: Orthosoft, Inc., Montreal, Quebec, Canada. Firm initiated recall is complete.
REASON
The three-point array may break during use, resulting in surgical delay and an increased risk of infection.
VOLUME OF PRODUCT IN COMMERCE
239 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room, Recall # Z-2459-2008
CODE
Lot numbers: PB070799 PB060399 PB060413 PB080901 PB070523 PBO80944 PB060414 PB060333 PB070817 PB070677 PB070669 PB PB060478 PB060207 PB080873 PB060234 PB060346 PB070605 PB060370 PB060461 OA040136R PB070844 PB070684 PB060421 PB060384 PB080890 PB060306 PB070837 PB070649 PB070638 OA050455 PB060192 PB070788 PB070746 PB060500 PB060227 PB070533 PB080999 PB060291 PB050140 PB070853 PB070673 PB070733 PB080980 PB070852 PB060511 PB060510 PB060383 PB060342 PB060502 PB080948 PB060465 PB060362 PB080995 OA050421 PB070749 PB070571 PB070718 PB080878 PB070861 PB060338 PB060353 PB070606 PB060386 PB050153 PB080953 OJ060318 OA040179R OJ060389 OJ060393 OJ060388 OJ060378 OJ060437 OJ060434 OJ060435 OJ060432 OJ060433 OJ070476 OJ070477 OJ070464 OJ070462 OJ070465 OJ070466 OJ070463 OJ070461 OJ070455 OJ070460 OJ070459 OJ070458 OJ070457 OJ070456 OJ070478 OJ070505 OJ070510 OJ070535 OJ070534 OJ070532 OJ070533 OJ070531 OJ070530 OJ070446 PB070591 PB070590 PB070754 PB070753 PB070765 PB070767 PB070766 PB070770 PB070771 PB070772 PB060191 PB070769 PB080924 OJ070498 OJ070489 OJ070527 OJ080542 OJ080555 OJ060314 OJ060341 OJ070479 OJ080548 OJ080554 OJ080553 OJ080560 OJ080581 OJ080559 OJ060321 OJ060320 OJ060323 OJ060322 OJ060324 OJ060325 OJ060327 OJ060328 OJ060326 PB060393 PB060469 PB070579 PB070582 PB070583 PB070580 PB070581 PB070578 PB070593 PB070665 and PB070820
RECALLING FIRM/MANUFACTURER
Cardinal Health NeuroCare Division, Madison, WI, by letter dated June 23, 2008. Firm initiated recall is ongoing.
REASON
NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.
VOLUME OF PRODUCT IN COMMERCE
274 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). Catalog #12-658, Recall # Z-2460-2008
CODE
Lot #066T28
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cholestech Corp., Hayward, CA, by letter dated August 3, 2006.
Manufacturer: Provalis Diagnostics Limited, Deeside, Flintshire CH5 2NU, UK. Firm initiated recall is complete.
REASON
Stability data indicated that the product would not meet performance claims through the end of its shelf life.
VOLUME OF PRODUCT IN COMMERCE
9,324 cartridges
DISTRIBUTION
Nationwide, India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
___________________________________
PRODUCT
Quick Connect component p/n 201048. The component is contained in: a) QPC1713 and b) QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K Series GI Endoscopes with Water Jet to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System. The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES without Water Jet to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System, Recall # Z-2462-2008
CODE
a) Serial #: 3870300, 3870367, 3870326, 3870342, 3923281, 3954195, 4008389, 4045720, 4091419, 4153292, 4201828, 4274429, 4297354, 4247052, C601846, C601879, 4569117, 4710430, 4770715, 4862314, 4899068, 4942173, 5005517, 5098421, and 5261433;
b) Serial # 3500782, 3531266, 3614856, 3644010, 3681319, 3753928, 3753944, 3754231, 3864709, 3865110, 3879319, 3935418, 3962214, 3967825, 4054979, 4123873, 4186201, C601848, 4274445, 4363339, 4247078, 4479853, 4588679, 4632667, 4684007, 4738753, 4802294, 4810867, 4869749, 4899084, 4942199, 4952487, 4987020, 5026513, 5063789, 5098447, 5159215, 5211669, 5256367, and 5257266
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letter dated August 4, 2008.
Manufacturer: Steris Corp., Hopkins Facility, Mentor, OH. Firm initiated recall is ongoing.
REASON
During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barlock may interfere with the top surface of bottom barb of the adapter. The interference may cause the plunger on the suction side to lift slightly which may affect flow of sterilant into the suction lumen.
VOLUME OF PRODUCT IN COMMERCE
a) 108 units; b) 557 units
DISTRIBUTION
Nationwide, Canada, Australia, Italy, Spain, and Thailand
___________________________________
PRODUCT
Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable. ID number EYZ4E, Recall # Z-2136-2008
CODE
Serial numbers: 1024 to 1189; but excluding 1053, 1057, 1089, 1096, 1097, 1098, 1101, 1103, 1161, 1166, 1173, 1176, 1177, 1178, 1180, 1181, 1185, 1186, 1187 and 1188
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letters on/about May 16, 2008.
Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Firm initiated recall is ongoing.
REASON
The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices. Ref 32216, Recall # Z-2240-2008
CODE
Lot number: 403504
RECALLING FIRM/MANUFACTURER
Nobel Biocare USA, LLC, Yorba Linda, CA, by telephone and letters beginning on November 2, 2007. Firm initiated recall is complete.
REASON
The NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the implant as "4.3x8". Since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ocular Conformer, Sterile. The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process. Catalog number: 9574, Catalog number 9548, Catalog number 9549, Catalog number 9779, and Catalog number 9780, Recall # Z-2302-2008
CODE
Lot number 001061103C, Lot number 002010204-C, Lot number 003061103C, Lot number 002050804C, Lot number 006101204-C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Porex Surgical, Inc., Newnan, GA, by phone on March 28, 2008 and follow-up letter on/about March 31, 2008.
Manufacturer: R.O. Gulden & Co., Inc., Elkins Park, PA. Firm initiated recall is complete.
REASON
The Ocular Conformers were distributed with an expired expiration date.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
PA, Canada and Germany
___________________________________
PRODUCT
Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL'; Each kit provides reagents sufficient for a maximum of 100 tests. Item number 64945/93, Recall # Z-2303-2008
CODE
Lot # 8055, Exp. August 31, 2009
RECALLING FIRM/MANUFACTURER
EMD Chemicals, Inc., Gibbstown, NJ, by e-mail and letter on June 4, 2008. Firm initiated recall is ongoing.
REASON
Two complaints that kit was not performing properly with positive controls.
VOLUME OF PRODUCT IN COMMERCE
29 kits (a kit of 4 bottles)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually packaged, 10 tubes per carton; Product is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route. Catalog/reorder number 20-1225AIV, Recall # Z-2306-2008
CODE
Lot number: 32601
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated June 25, 2008.
Manufacturer: VIASYS Medsystems, Wheeling, IL. Firm initiated recall is ongoing.
REASON
The male Luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.
VOLUME OF PRODUCT IN COMMERCE
807 tubes
DISTRIBUTION
CA, IL, KY and MO
___________________________________
PRODUCT
Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Catalog Number: 100-25, Recall # Z-2311-2008
CODE
Lots Numbers: FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003, FC0805004
RECALLING FIRM/MANUFACTURER
Stryker Biotech, Hopkinton, MA, by letters dated June 24, 2008, June 30, 2008 and July 1, 2008. Firm initiated recall is ongoing.
REASON
Product package insert misprint-text offset.
VOLUME OF PRODUCT IN COMMERCE
803 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits, Recall # Z-2322-2008;
b) Medtronic Patient programmer, model 37742. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to tun therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits, Recall # Z-2323-2008
CODE
a) and b) Serial numbers: NJD058707N, NJD062024N, NJD063259N, and NJD063324N
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letters and visits beginning May 12, 2008.
Manufacturer: Benchmark Electronics Inc., Winona, MN. Firm initiated recall is ongoing.
REASON
Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA, MO, NC, TX
___________________________________
PRODUCT
Integra Dermal Regeneration Template; 8 x 10 in. (20 cm x 25 cm), Sterile; Catalog number 38101, Recall # Z-2328-2008
CODE
Lot Number: 105BA0121823
RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp., Plainsboro, NJ, by letter on July 2, 2008. Firm initiated recall is ongoing.
REASON
Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
TN, CA, NY, IN and AL
END OF ENFORCEMENT REPORT FOR OCTOBER 22, 2008
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